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1.
Trials ; 25(1): 453, 2024 Jul 04.
Article in English | MEDLINE | ID: mdl-38965585

ABSTRACT

BACKGROUND: Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment. METHOD: The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site. DISCUSSION: We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe. TRIAL REGISTRATION: ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php -use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).


Subject(s)
Cleft Lip , Cleft Palate , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Humans , Cleft Lip/surgery , Cleft Lip/therapy , Cleft Palate/surgery , Cleft Palate/therapy , Infant , Single-Blind Method , Treatment Outcome , Infant, Newborn , India , Esthetics , Alveolar Process/surgery , Female , Male , Nose/abnormalities , Palatal Obturators
2.
Article in English | MEDLINE | ID: mdl-38887900

ABSTRACT

OBJECTIVES: Dental antibiotic stewardship is crucial in low- and middle-income countries where the burden of antimicrobial resistance (AMR) is high and antibiotic misuse is common. Given that India is the most populous country, the largest antibiotic consumer and has a large dental prescriber population, this study investigated the extent to which current Indian policy and practice for dental antibiotic prescribing and stewardship aligns with the global policy and best practice. METHODS: The READ approach was used to identify and extract data and synthesize the findings. Policy documents on dental antimicrobial stewardship were identified using a systematic search strategy involving nine medical and grey literature databases (Medline, Global Health, Web of Science, Cochrane, CINAHL, Eldis, Global Index Medicus, Proquest and Opengrey), targeted websites (government organizations and dental regulatory bodies) and contact with experts. Framework analysis was used to code extracted data into themes related to dental antimicrobial stewardship. RESULTS: Of the 3039 records screened, 25 documents were included in the final analysis. The analysis showed a lack of guidelines or toolkits for appropriate antibiotic prescribing in dentistry in India. The treatment guidelines for antimicrobial use in common syndromes published by the Indian Council of Medical Research had no section or content for dental practitioners. Furthermore, the undergraduate dental curriculum developed by the Dental Council of India (DCI), included little content on appropriate antibiotic prescribing and no mention of AMR or stewardship. There were no educational resources either for dental practitioners or patients in the documents. CONCLUSION: This document analysis showed that there was little or no mention of dental antibiotic prescribing guidelines in key policy documents such as the National Action Plan on AMR. In addition, contradictory and subjective information provided in some policy documents could encourage dentists and other health professionals such as general practitioners to prescribe antibiotics for common dental conditions for which they are contra-indicated. There is an urgent need to develop relevant guidelines and include these in Indian policy documents on AMR particularly the National Action Plan on AMR.

3.
Orthod Craniofac Res ; 27 Suppl 1: 90-99, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38108550

ABSTRACT

The aim of this systematic review was to compare the effectiveness of pre-alveolar bonegraft (ABG) orthodontics with no orthodontic treatment for patients with non-syndromic unilateral cleft lip, alveolus and palate. All relevant studies from 1946 to October 30, 2022, were identified using several sources including The Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, Scopus, EMBASE, MEDLINE (Ovid) and EPUB ahead of publications and non-indexed citations. Randomized Controlled Trials (RCT) and Controlled Clinical Trials (CCT) were included. POPULATION: Non-syndromic complete unilateral cleft lip, alveolus and palate patients who have had ABG surgery. INTERVENTION: Orthodontics prior to ABG. Comparison: No orthodontic treatment prior to ABG. PRIMARY OUTCOME: Successful eruption of permanent canines. All articles were screened for the title, abstract and full text independently and in duplicate by 2 reviewers. The quality assessment of RCT was performed using Cochrane's risk of bias tool and the CCT was assessed using ROBINS-I tool. Of the 904 studies retrieved in the search, one RCT and one CCT were included. Both studies were judged as high risk of bias. The results from one study showed a statistically significant increase in bone volume and decreased bone defect post-ABG in the orthodontic treatment group. However, there was no difference with respect to other variables. Both included studies were of low quality. There is not enough evidence to recommend orthodontic treatment pre-ABG for patients with complete unilateral cleft lip, alveolus and palate. Future high-quality studies are required to inform patients and clinicians about the effectiveness of pre-graft orthodontic treatment.


Subject(s)
Alveolar Bone Grafting , Cleft Lip , Cleft Palate , Humans , Cleft Palate/surgery , Cleft Lip/surgery , Alveolar Bone Grafting/methods , Orthodontics, Corrective/methods , Treatment Outcome , Bone Transplantation/methods
4.
Cleft Palate Craniofac J ; : 10556656231201491, 2023 Sep 16.
Article in English | MEDLINE | ID: mdl-37715652

ABSTRACT

OBJECTIVE: To assess the factors influencing the type and timing of Alveolar Bone Grafting (ABG) among cleft centers throughout India. To examine the decision-making criteria for orthodontic treatment and the timing of ABG. DESIGN: Cross sectional survey. METHOD: This survey was based on a convenience-based sample selected from cleft teams across India. The survey was formulated using the SurveyMonkey platform and emailed to 40 cleft teams. The survey included questions on demographics, timing, surgical protocol, orthodontic protocol, radiograph prescription rate, assessment methods for the success of ABG and three scenarios for evaluating the timing of the bone graft. The Chi-squared test was performed to evaluate the difference in opinion between specialists. The inter-examiner reliability was assessed using Kappa statistics. RESULTS: Thirty-five units completed the questionnaire. Most units operate with 1-2 surgeons, with 42.9% of them treating cleft patients for under 5 years. Only 11.4% of centres routinely advised oblique occlusal radiographs for post-surgery evaluation, and 31.4% prescribed CBCT. However, 40% of cleft teams did not perform audits to evaluate the success of ABG, and less than 50% advised radiographs six months post-surgery. Around 26% of centres do not routinely provide orthodontic treatment pre-ABG. The inter-examiner reliability for case scenarios showed poor agreement between the clinicians. CONCLUSION: The survey showed a serious lack of consensus in the ABG treatment among cleft teams in India and emphasises the need for standardised protocols for the treatment of children with cleft palate. There is an urgent need to develop core outcome set in cleft.

5.
Front Med (Lausanne) ; 10: 1220505, 2023.
Article in English | MEDLINE | ID: mdl-37724176

ABSTRACT

Aim: To evaluate the impact of COVID-19 on clinical orthodontic services, orthodontic education, and the emotional well-being of orthodontists and orthodontic trainees in India. Materials and methods: The survey was designed using Survey Monkey™ and distributed to members of the Indian Orthodontic Society via their registered email address and also via social media platforms (WhatsApp and LinkedIn). Results: A total of 610 responses to the survey were received. The majority of respondents agreed on the negative impact of COVID-19 on clinical activity and the associated income of orthodontists. Respondents reported that this was mainly due to national restrictions (70.1%), increased cross infection measures (59.6%), state restrictions (55.9%), and social distancing (39.4%). Ninety one percent of respondents agreed that orthodontic staff should have evidence of vaccination before providing care.COVID-19 was found to have a negative impact on the trainees' perceptions of their clinical dexterity (72.4%), their confidence with respect to academic knowledge (66.5%), their mental health (80.7%), and their stress levels during the pandemic (93.2%). Conclusion: The COVID-19 pandemic has had a negative impact on orthodontic specialists and post-graduate trainees in India. The impact on trainees' mental health was significantly higher compared to trainees from other countries. Decreased clinical activity has reduced the opportunities for learning, and trainers must rise to the challenge of providing additional support to this cohort of trainees who will progress to become the future orthodontic workforce.

7.
Am J Orthod Dentofacial Orthop ; 163(5): 677-689, 2023 May.
Article in English | MEDLINE | ID: mdl-36621351

ABSTRACT

INTRODUCTION: The Twin-block (TB) and the van Beek Headgear-Activator (vBHGA) are indicated for patients with Class II malocclusion with a retrognathic mandible. Although the former is commonly prescribed for horizontally growing patients, the latter is often recommended for those growing vertically. This study aimed to compare the skeletal, dentoalveolar, and soft-tissue short-term effects of TB and vBHGA, taking growth patterns into account. METHODS: Immediate prefunctional (T1) and postfunctional appliance (T2) lateral cephalometric radiographs were retrospectively obtained for vBHGA (n = 46), TB (n = 45), and untreated control (n = 45) groups. The interaction of several variables at T1, T2, and T2 - T1, as well as the resultant treatment effect, were analyzed using the analysis of covariance regression models at the 5% significance level. RESULTS: Except for a greater reduction in Wits measurement (3.0 mm; P <0.0001) in the TB group, no anteroposterior (AP) skeletal difference was observed between the 2 appliances (ANB, 0.530; P = 0.07) (Harvold, 0.13 mm; P = 0.81). Both improved the AP skeletal relationship (ANB and Harvold) compared with the control (P <0.05). Although this mostly occurred because of the forward positioning of the mandible with the TB (SNB, 0.960; P = 0.01), the maxillary restriction was the main mechanism with the vBHGA (SNA, 1.590; P <0.01). Dentoalveolar compensations were more pronounced with the TB (IMPA, 1.92; P = 0.02), leading to greater overbite and overjet correction. Only the inclination of the maxillary incisors showed interaction with the growth pattern, with the TB horizontal growers experiencing more retroclination (U1-NA°. 3.620; P = 0.0067). CONCLUSIONS: Both appliances produced similar modest AP skeletal changes that, together with dentoalveolar compensations, were able to correct the Class II malocclusion regardless of growth pattern.


Subject(s)
Malocclusion, Angle Class II , Overbite , Humans , Retrospective Studies , Malocclusion, Angle Class II/diagnostic imaging , Malocclusion, Angle Class II/therapy , Mandible/diagnostic imaging , Cephalometry , Maxilla
8.
Cleft Palate Craniofac J ; 60(5): 536-543, 2023 05.
Article in English | MEDLINE | ID: mdl-35099313

ABSTRACT

A national survey of cleft teams was undertaken to evaluate the current standard of care for patients with cleft lip and palate (CLP) in India as a part of Cleft Care India study.This was a cross-sectional questionnaire-based study.Cleft teams across India attending the 19th Annual Conference of the Indian Society of Cleft Lip and Palate were invited to complete the questionnaire. The questionnaire consisted of 18 questions that included demographics, institutional details, patient protocols, surgical technique, rehabilitation facilities, and accessibility. The data are descriptively reported.A total of 112 centers completed the survey. Nongovernment organizations funded 87% of the cleft centers and 8% did not receive any funding. Only 39% of the centers had centralized cleft services providing multidisciplinary care. Speech therapy was provided either onsite or through referral at 90% of the centers, whereas audiology was provided only at 4% of centers. Feeding advice was routinely provided in 52% of centers. Millard technique was the most preferred technique for unilateral cleft lip repair (66%). The 2-flap technique (37%) and pharyngeal flap (48%) were the most common surgeries for cleft palate and pharyngoplasty, respectively. Although 54% of centers reported their patients to be interested in comprehensive care, 43% reported that their patients only wanted surgical correction.There is wide diversity in access to cleft care and clinical practices across centers in India. Further work is needed to evaluate the quality of care by assessing outcomes of centers treating patients with CLP.


Subject(s)
Cleft Lip , Cleft Palate , Humans , Cleft Lip/surgery , Cleft Palate/surgery , Cross-Sectional Studies , Standard of Care , Surveys and Questionnaires
9.
Eur J Orthod ; 44(2): 210-225, 2022 Mar 30.
Article in English | MEDLINE | ID: mdl-34609513

ABSTRACT

BACKGROUND/OBJECTIVES: The aim of this systematic review was to compare the different force delivery systems for orthodontic space closure by sliding mechanics. SEARCH METHODS: Multiple sources including Cochrane Central, Ovid Medline, Embase etc. were used to identify all relevant studies. SELECTION CRITERIA: Randomized controlled trials (RCT) of parallel-group and split-mouth designs were included. PARTICIPANTS: Orthodontic patients of any age treated with fixed orthodontic appliances and requiring space closure. DATA COLLECTION AND ANALYSIS: Search result screening, data extraction and quality assessment were performed independently and in duplicate by 2 reviewers. The included studies were grouped into parallel-arm and split-mouth studies and subgroup analysis was then performed for the type of retraction subsets; en-masse and individual canine retraction. A traditional meta-analysis, and network meta-analysis (NMA) for direct and indirect comparisons for the rate of space closure were performed. RESULTS: Thirteen studies, six parallel-arm and seven split-mouth were included. The traditional meta-analysis comparing Nickel-titanium (NiTi) closed coil springs and elastomeric power chain for the rate of tooth movement showed statistically significant difference favouring NiTi springs (MD: 0.24; 95% CI, 0.03-0.45; I2 0%, P = 0.02) and the comparison between NiTi springs and active ligatures also showed statistically significant result favouring NiTi springs (MD: 0.53; 95% CI, 0.44-0.63; I2 0%, P ˂ 0.00001) for the rate of tooth movement. NMA for the rate of space closure showed fairly confident evidence for NiTi coil springs when compared with elastomeric chain and active ligatures. The NiTi coil spring ranked best between all methods of space closure. CONCLUSIONS: There is moderate quality evidence in favour of NiTi coil springs for the rate of space closure when compared with active ligature and low quality of evidence favouring NiTi springs when compared with elastomeric chain. The ranking from NMA showed NiTi coil springs to be the best method for space closure with 99% chance. An urgent need for standardization of study designs and the need for development of an agreed core outcome sets and core outcome instrument measurement sets is evident. REGISTRATION: PROSPERO CRD42020157811.


Subject(s)
Orthodontic Space Closure , Orthodontic Wires , Dental Alloys , Elasticity , Humans , Titanium , Tooth Movement Techniques
10.
Br Dent J ; 231(11): 682-688, 2021 12.
Article in English | MEDLINE | ID: mdl-34893726

ABSTRACT

The aim of this article is to outline the potential risks in orthodontic treatment and the general dental practitioner's role in reducing and managing such risks. The success of orthodontic treatment largely depends on patient understanding of the risk/benefit implications of the orthodontic treatment and all of the potential consequences involved in such treatment. A perfect blend of good case selection, sound clinical judgement and, more importantly, a patient's clear understanding of the potential risks involved and the treatment implications help minimise and manage potential hazards that occur during the course of the treatment.


Subject(s)
Dentists , Professional Role , Dental Care , Humans
11.
Trials ; 22(1): 572, 2021 Aug 28.
Article in English | MEDLINE | ID: mdl-34454599

ABSTRACT

BACKGROUND: An alveolar cleft commonly affects 75% of cleft lip and palate patients. While it is common practice to provide a course of orthodontic treatment before alveolar bone grafting, there are no previous high-quality studies reporting on the benefits of this type of treatment. AIM: The aim of the study is to evaluate the effectiveness of pre-alveolar bone graft orthodontics for unilateral non-syndromic cleft palate patients. METHOD: The PABO trial is a multicentric, parallel, two-arm, single-blinded randomised controlled trial. The inclusion criteria include unilateral cleft alveolus patients requiring bone graft and between the age group of 8 and 13 years with erupted upper central incisors. Participants will be recruited at three centres across India. Participants will be randomised to orthodontic treatment or no orthodontic treatment group. Both groups of participants will have alveolar bone graft surgery and will be followed up for 6 months after surgery. The primary outcome will be the success of the alveolar bone graft measured by anterior oblique radiograph and secondary outcomes include quality of life, cost analysis and quality of the dento-occlusal outcome. Data analysis will be carried out by an independent statistician at the end of the study. DISCUSSION: This study is the first to evaluate the effect of orthodontics on alveolar bone graft success. The increased burden of care for these patients with multiple treatments required from multiple specialists from birth to adult life highlights the need for reducing unnecessary treatment provision. TRIAL REGISTRATION: Clinical Trials Registry - India, CTRI/2020/10/028756 . Trial prospectively registered on 29 October 2020. .


Subject(s)
Alveolar Bone Grafting , Cleft Lip , Cleft Palate , Orthodontics , Adolescent , Adult , Child , Cleft Lip/diagnostic imaging , Cleft Lip/surgery , Cleft Palate/diagnostic imaging , Cleft Palate/surgery , Humans , Quality of Life , Randomized Controlled Trials as Topic
12.
J World Fed Orthod ; 10(2): 43-48, 2021 06.
Article in English | MEDLINE | ID: mdl-33893064

ABSTRACT

BACKGROUND AND OBJECTIVES: Class II malocclusion is one of the most common orthodontic problems. The Twin Block appliance has proven to be the most popular appliance for the correction of these malocclusions. Although randomized controlled trials (RCTs) on the Twin Block appliance have reported the changes to be mainly dentoalveolar, several nonrandomized studies have reported a significant skeletal improvement in these patients. Hence, the aim of this study was to compare the effectiveness of Twin Block appliance evaluated using an RCT or retrospectively selected cases (RSC) for the treatment of Class II Division 1 malocclusion in an adolescent population. METHODS: This was a retrospective study. The results for an RCT were selected from a UK Class II multicenter study. Sixty-three patients from the trial were included. This group was matched with retrospectively selected Class II cases treated with a Twin Block functional appliance and their results submitted for Membership in Orthodontics examination in the United Kingdom, from four centers. The primary outcome was skeletal measurement ANB (A point, nasion, B point). Secondary outcomes included final peer assessment rating (PAR) scores and final overjet. Intrarater reliability of measurements was assessed. Independent samples t-test was carried out to look at the difference between the groups. RESULTS: The reliability assessment showed excellent agreement for all measurements. The data were normally distributed. There was a statistically significant difference favoring the RSC group for final overjet (mean difference [MD] = 1.068, 95% confidence interval [CI] -0.67 to 1.47, P = 0.000) and final PAR (MD = 4.0, 95% CI -0.79 to 5.5, P = 0.000). There was no significant difference in the scores for final ANB (MD = 0.34, 95% CI -0.39 to 1.07, P = 0.33). CONCLUSION: The RSCs show significantly improved overjet and PAR scores at the end of treatment and no statistically significant difference for skeletal change. The study raises the question of a potential role of observational studies in evaluating the effect of an intervention in orthodontics.


Subject(s)
Malocclusion, Angle Class II , Orthodontic Appliances, Functional , Adolescent , Humans , Malocclusion, Angle Class II/therapy , Orthodontics, Corrective , Retrospective Studies , Treatment Outcome
13.
Br Dent J ; 230(6): 345-350, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33772187

ABSTRACT

Dens invaginatus (DI) is a developmental anomaly resulting in a deepening or invagination of the enamel organ into the dental papilla prior to calcification of the dental tissues. Presence of DI is considered to increase the risk of caries and pulpal pathology, but they are often missed in the initial orthodontic assessment as they present with no clinical signs of an anomaly. In absence of adequate oral hygiene and maintenance, bacterial contamination of these malformations can lead to the development of early caries and consequent pulpal death. Early diagnosis of these lesions is critical as they can negatively impact any planned orthodontic treatment and assessment of the prognosis of these lesions is therefore necessary prior to the commencement of orthodontic treatment. In this article, we aim to illustrate the need for appropriate diagnosis and multidisciplinary approach in the management of DI in patients undergoing orthodontic treatment.


Subject(s)
Dens in Dente , Dental Caries , Dens in Dente/diagnosis , Dens in Dente/therapy , Dental Caries/therapy , Dental Pulp , Humans , Oral Hygiene
15.
Am J Orthod Dentofacial Orthop ; 157(6): 738-744.e10, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32487303

ABSTRACT

INTRODUCTION: Currently, there is limited evidence on the effects of malocclusion on oral health and whether the correction of malocclusion results in an improvement in oral health. In this review, we examined the evidence from randomized controlled trials and prospective cohort studies to provide information on any association between malocclusion and oral health and the effects of orthodontic treatment. METHODS: We conducted this review in 2 parts: (1) we looked at the impact of malocclusion on oral health, and (2) we reviewed the evidence on the effect of orthodontic treatment on oral health. We searched for randomized controlled trials and prospective cohort studies. The searches were completed for articles published between January 1, 1990 and October 8, 2018 and covered Medline via Ovid, Embase, and the Cochrane Database of Systematic Reviews. References of included articles and previous systematic reviews were hand-searched. No language restrictions were applied. Two members of the study team assessed the quality of the studies using the Appraisal Tool for Cross-Sectional Studies to appraise the quality of studies in part 1. The assessment was performed at the study level. Two authors assessed each study independently, with a third author consulted when a disagreement occurred. For studies in part 2, we used the Newcastle-Ottawa scale to assess the risk of bias. When studies were included in a Cochrane review, we incorporated the risk of bias assessment. We developed data extraction forms for each area of oral health under investigation (trauma, quality of life, caries, and periodontal disease). Each author piloted the form, and we held discussions to inform any necessary refinements. We extracted data from studies into 2 × 2 tables, which provided a binary analysis of malocclusion vs the outcome of interest. If these data were not available from the published paper, then studies were not included in the meta-analysis. The authors were contacted when possible to request data in this format. RESULTS: For part 1 of the study, we identified 87 studies. The overall quality was low. We could not include any of the data into an analysis because of a large variation in the nature of the studies, data collected, and outcome measures that were selected. For part 2 of the study, we found 7 studies; however, there were similar deficiencies in the data as in part 1, and thus, we could not reach any strong conclusions. CONCLUSIONS: Overall, there is an absence of published evidence regarding the effects of malocclusion on oral health and the impact of orthodontic treatment on oral health.


Subject(s)
Malocclusion , Oral Health , Cross-Sectional Studies , Humans , Prospective Studies , Quality of Life
16.
J Evid Based Dent Pract ; 19(3): 273-282, 2019 09.
Article in English | MEDLINE | ID: mdl-31732103

ABSTRACT

OBJECTIVES: The objective of this study was to assess the characteristics and level of evidence (LOE) of clinical studies recently published in leading orthodontic journals and to explore the association between the LOE and potentially related factors. METHODS: The official online archives of 5 leading orthodontic journals were hand-searched to identify clinical research articles published during the period 2015-2017. The LOE of all included studies was assessed using a modified LOE classification system developed based on the Oxford LOE and Grading of Recommendations Assessment, Development and Evaluation (GRADE). Univariable and multivariable logistic regression analyses were performed to identify the association between the LOE of each article (high LOE vs. low LOE) and 7 factors. RESULTS: A total of 637 studies were included and assessed. Of these, 8 (1.3%) were of level 1, 160 (25.1%) level 2, 326 (51.2%) level 3, and 143 (22.4%) level 4. According to multivariable logistic regression analyses, journal of publication (P < .001), funding status (P = .003), and the geographic origin of the first author (P = .006) were significantly associated with the LOE. CONCLUSIONS: The number of studies with high LOE in leading orthodontic journals was limited. There is still need for further improvement in the overall LOE of clinical studies in orthodontics.


Subject(s)
Orthodontics , Periodicals as Topic , Bibliometrics , Humans , Journal Impact Factor
17.
Am J Orthod Dentofacial Orthop ; 155(1): 19-27.e3, 2019 Jan.
Article in English | MEDLINE | ID: mdl-30591159

ABSTRACT

INTRODUCTION: Intention-to-treat (ITT) analysis is an approach to managing dropouts and missing data in randomized controlled trials (RCTs). In this study, we systematically reviewed orthodontic RCTs to assess the frequency that an ITT analysis was carried out, to compare the number of trials that reported using ITT analyses with those that had truly used it, and to evaluate how dropouts and missing data were managed. METHODS: Systematic searches were conducted in electronic databases including Cochrane Oral Health's Trials Register (searched on November 30, 2016) and Cochrane Central Register of Controlled Trials (2016) in the Cochrane Library (searched on November 30, 2016), with no restrictions on language, publication year, or publication status. RCTs comparing orthodontic or orthopedic treatments, or comparing orthodontic or orthopedic treatment with a control group without intervention were included. A customized data collection form was created, piloted, and used to gather information from the selected studies. The data extraction was performed by 2 authors independently and in duplicate, with disagreements resolved by discussion with the third author. The studies were assessed for attrition bias. The data were grouped and classified according to 2 categorical variables: sample analyzed and missing data strategy. The results were reported in percentages and descriptively. RESULTS: From the 55 RCTs identified, 6 reported using an ITT approach. From these, only 1 study carried out a true ITT analysis (2%). From the 49 RCTs that did not report using an ITT analysis, 12 had used it (22%). The most used method of analyzing missing data was "completer sample" with 19 studies using this method (28%). "Full random sample" and "sufficient dose" were similar, with 13 and 11 studies, respectively (16% and 14%). The most frequently used missing data strategy for studies that did not conduct a true ITT analysis was "sample followed" with 30 studies (81%). For the studies that conducted a true ITT analysis, the most observed missing data strategy was "no dropouts" with 11 studies (79%). CONCLUSIONS: Less than a third of the RCTs in orthodontics used an ITT analysis. There is a potential lack of understanding on dropouts and missing data management in research on orthodontic treatment.


Subject(s)
Intention to Treat Analysis , Orthodontics , Patient Dropouts , Humans
18.
Cochrane Database Syst Rev ; 3: CD003452, 2018 03 13.
Article in English | MEDLINE | ID: mdl-29534303

ABSTRACT

BACKGROUND: Prominent upper front teeth are a common problem affecting about a quarter of 12-year-old children in the UK. The condition develops when permanent teeth erupt. These teeth are more likely to be injured and their appearance can cause significant distress. Children are often referred to an orthodontist for treatment with dental braces to reduce the prominence of their teeth. If a child is referred at a young age, the orthodontist is faced with the dilemma of whether to treat the patient early or to wait and provide treatment in adolescence. OBJECTIVES: To assess the effects of orthodontic treatment for prominent upper front teeth initiated when children are seven to 11 years old ('early treatment' in two phases) compared to in adolescence at around 12 to 16 years old ('late treatment' in one phase); to assess the effects of late treatment compared to no treatment; and to assess the effects of different types of orthodontic braces. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 27 September 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 8), MEDLINE Ovid (1946 to 27 September 2017), and Embase Ovid (1980 to 27 September 2017). The US National Institutes of Health Ongoing Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: Randomised controlled trials of orthodontic treatments to correct prominent upper front teeth (Class II malocclusion) in children and adolescents. We included trials that compared early treatment in children (two-phase) with any type of orthodontic braces (removable, fixed, functional) or head-braces versus late treatment in adolescents (one-phase) with any type of orthodontic braces or head-braces, and trials that compared any type of orthodontic braces or head-braces versus no treatment or another type of orthodontic brace or appliance (where treatment started at a similar age in the intervention groups).We excluded trials involving participants with a cleft lip or palate, or other craniofacial deformity/syndrome, and trials that recruited patients who had previously received surgical treatment for their Class II malocclusion. DATA COLLECTION AND ANALYSIS: Review authors screened the search results, extracted data and assessed risk of bias independently. We used odds ratios (ORs) and 95% confidence intervals (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used the fixed-effect model for meta-analyses including two or three studies and the random-effects model for more than three studies. MAIN RESULTS: We included 27 RCTs based on data from 1251 participants.Three trials compared early treatment with a functional appliance versus late treatment for overjet, ANB and incisal trauma. After phase one of early treatment (i.e. before the other group had received any intervention), there was a reduction in overjet and ANB reduction favouring treatment with a functional appliance; however, when both groups had completed treatment, there was no difference between groups in final overjet (MD 0.21, 95% CI -0.10 to 0.51, P = 0.18; 343 participants) (low-quality evidence) or ANB (MD -0.02, 95% CI -0.47 to 0.43; 347 participants) (moderate-quality evidence). Early treatment with functional appliances reduced the incidence of incisal trauma compared to late treatment (OR 0.56, 95% CI 0.33 to 0.95; 332 participants) (moderate-quality evidence). The difference in the incidence of incisal trauma was clinically important with 30% (51/171) of participants reporting new trauma in the late treatment group compared to only 19% (31/161) of participants who had received early treatment.Two trials compared early treatment using headgear versus late treatment. After phase one of early treatment, headgear had reduced overjet and ANB; however, when both groups had completed treatment, there was no evidence of a difference between groups in overjet (MD -0.22, 95% CI -0.56 to 0.12; 238 participants) (low-quality evidence) or ANB (MD -0.27, 95% CI -0.80 to 0.26; 231 participants) (low-quality evidence). Early (two-phase) treatment with headgear reduced the incidence of incisal trauma (OR 0.45, 95% CI 0.25 to 0.80; 237 participants) (low-quality evidence), with almost half the incidence of new incisal trauma (24/117) compared to the late treatment group (44/120).Seven trials compared late treatment with functional appliances versus no treatment. There was a reduction in final overjet with both fixed functional appliances (MD -5.46 mm, 95% CI -6.63 to -4.28; 2 trials, 61 participants) and removable functional appliances (MD -4.62, 95% CI -5.33 to -3.92; 3 trials, 122 participants) (low-quality evidence). There was no evidence of a difference in final ANB between fixed functional appliances and no treatment (MD -0.53°, 95% CI -1.27 to -0.22; 3 trials, 89 participants) (low-quality evidence), but removable functional appliances seemed to reduce ANB compared to no treatment (MD -2.37°, 95% CI -3.01 to -1.74; 2 trials, 99 participants) (low-quality evidence).Six trials compared orthodontic treatment for adolescents with Twin Block versus other appliances and found no difference in overjet (0.08 mm, 95% CI -0.60 to 0.76; 4 trials, 259 participants) (low-quality evidence). The reduction in ANB favoured treatment with a Twin Block (-0.56°, 95% CI -0.96 to -0.16; 6 trials, 320 participants) (low-quality evidence).Three trials compared orthodontic treatment for adolescents with removable functional appliances versus fixed functional appliances and found a reduction in overjet in favour of fixed appliances (0.74, 95% CI 0.15 to 1.33; two trials, 154 participants) (low-quality evidence), and a reduction in ANB in favour of removable appliances (-1.04°, 95% CI -1.60 to -0.49; 3 trials, 185 participants) (low-quality evidence). AUTHORS' CONCLUSIONS: Evidence of low to moderate quality suggests that providing early orthodontic treatment for children with prominent upper front teeth is more effective for reducing the incidence of incisal trauma than providing one course of orthodontic treatment in adolescence. There appear to be no other advantages of providing early treatment when compared to late treatment. Low-quality evidence suggests that, compared to no treatment, late treatment in adolescence with functional appliances, is effective for reducing the prominence of upper front teeth.


Subject(s)
Malocclusion, Angle Class II/therapy , Orthodontic Appliances, Functional , Orthodontic Retainers , Orthodontics, Corrective/methods , Adolescent , Age Factors , Child , Extraoral Traction Appliances , Humans , Orthodontic Appliances, Functional/adverse effects , Orthodontic Retainers/adverse effects , Orthodontics, Corrective/adverse effects , Randomized Controlled Trials as Topic , Treatment Outcome
19.
Am J Orthod Dentofacial Orthop ; 152(4): 509-515, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28962736

ABSTRACT

INTRODUCTION: Maxillary canines are generally considered important both cosmetically and functionally. Most claims on the importance of maxillary canines, however, have been based on expert opinions and clinician-based studies. There are no scientific studies in the literature reporting on their cosmetic importance or how laypeople perceive a smile treated by maxillary canine extractions. Our objective was to investigate whether there is any difference in the perceptions of patients' smiles treated by extracting either maxillary canines or first premolars, as judged by orthodontists, dentists, and laypeople. METHODS: This retrospective study included 24 participants who had unilateral or bilateral extraction of maxillary permanent canines and fixed appliances in the maxillary and mandibular arches to comprehensively correct the malocclusion, selected from orthodontic patients treated at Chesterfield Royal Hospital NHS trust in the United Kingdom over the last 20 years. The control group of patients had extraction of maxillary first premolars followed by fixed appliances and finished to an extremely high standard judged by the requirement that they had been submitted for the Membership in Orthodontics examination. The finished Peer Assessment Rating scores for this group were less than 5. The end-of-treatment frontal extraoral smiling and frontal intraoral views were presented for both groups. The photographs were blinded for extraction choice and standardized for size and brightness using computer software (Adobe Photoshop CC version 14.0; Adobe Systems, San Jose, Calif). The work file was converted to an editable pdf file and e-mailed to the assessors. The assessor panel consisted of 30 members (10 orthodontists, 10 dentists, and 10 laypeople), who were purposely selected. The measures were rated on a 10-point Likert scale. RESULTS: The attractiveness ratings were not statistically significantly different between the canine extraction and premolar extraction groups, with a mean difference of 0.33 (SD, 0.29) points. A 1-way repeated-measures analysis of variance to test the difference in scores among the laypeople, orthodontists, and dentists (n = 30) showed no statistically significant difference (Wilks lambda = 0.835; P = 0.138), and the Bonferroni test indicated that no pair-wise difference was statistically significant. CONCLUSIONS: No statistically significant difference was found in the smile attractiveness between canine extraction and premolar extraction patients as assessed by general dentists, laypeople, and orthodontists. Further high-quality studies are required to evaluate the effect of canine extraction and premolar substitution on functional occlusion.


Subject(s)
Attitude of Health Personnel , Cuspid/surgery , Esthetics, Dental , Smiling , Tooth Extraction , Female , Humans , Male , Malocclusion/therapy , Maxilla , Orthodontics, Corrective , Retrospective Studies
20.
Am J Orthod Dentofacial Orthop ; 151(1): 28-52, 2017 Jan.
Article in English | MEDLINE | ID: mdl-28024779

ABSTRACT

INTRODUCTION: Class III malocclusion affects between 5% and 15% of our population. The 2 most common dilemmas surrounding Class III treatment are the timing of treatment and the type of appliance. A number of appliances have been used to correct a Class III skeletal discrepancy, but there is little evidence available on their effectiveness in the long term. Similarly, early treatment of Class III malocclusion has been practiced with increasing interest. However, there has been no solid evidence on the benefits in the long term. The aim of this systematic review was to evaluate the effectiveness of orthodontic/orthopedic methods used in the early treatment of Class III malocclusion in the short and long terms. METHODS: Several sources were used to identify all relevant studies independently of language. The Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase (Ovid), and MEDLINE (Ovid) were searched to June 2016. The selection criteria included randomized controlled trials (RCTs) and prospective controlled clinical trials (CCTs) of children between the ages of 7 and 12 years on early treatment with any type of orthodontic/orthopedic appliance compared with another appliance to correct Class III malocclusion or with an untreated control group. The primary outcome measure was correction of reverse overjet, and the secondary outcomes included skeletal changes, soft tissue changes, quality of life, patient compliance, adverse effect, Peer Assessment Rating score, and treatment time. The search results were screened for inclusion, and the data extracted by 2 independent authors. The data were analyzed using software (version 5.1, Review Manager; The Nordic Cochrane Centre, The Cochrane Collaboration; Copenhagen, Denmark). The mean differences with 95% confidence intervals were expressed for the continuous data. Random effects were carried out with high levels of clinical or statistical heterogeneity and fixed affects when the heterogeneity was low. RESULTS: Fifteen studies, 9 RCTs and 6 CCTs, were included in this review. In the RCT group, only 3 of 9 studies were assessed at low risk of bias, and the others were at high or unclear risk of bias. All 6 CCT studies were classified as high risk of bias. Three RCTs involving 141 participants looked at the comparison between protraction facemask and untreated control. The results for reverse overjet (mean difference, 2.5 mm; 95% CI, 1.21-3.79; P = 0.0001) and ANB angle (mean difference, 3.90°; 95% CI, 3.54-4.25; P <0.0001) were statistically significant favoring the facemask group. All CCTs demonstrated a statistically significant benefit in favor of the use of each appliance. However, the studies had high risk of bias. CONCLUSIONS: There is a moderate amount of evidence to show that early treatment with a facemask results in positive improvement for both skeletal and dental effects in the short term. However, there was lack of evidence on long-term benefits. There is some evidence with regard to the chincup, tandem traction bow appliance, and removable mandibular retractor, but the studies had a high risk of bias. Further high-quality, long-term studies are required to evaluate the early treatment effects for Class III malocclusion patients. TRIAL REGISTRATION NUMBER: PROSPERO CRD42015024252.


Subject(s)
Malocclusion, Angle Class III/therapy , Orthodontics, Corrective/methods , Humans , Treatment Outcome
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