A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial.

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).

An In Vivo Study to Compare the Clinical Effectiveness of Clear Retainer Made on a Conventional and a Digitally Fabricated Model Over a Six-Month Period After Debonding.

Background With the advent of 3D printing, many more possibilities have arisen for treatment planning. 3D rapid prototyping has enabled us to see a whole other dimension that has helped us to give the best possible care for our patients. With more and more advancements being made in this subject, it becomes necessary to check the reliability of the equipment and its effectiveness in the management of the problem at hand. This original study was conducted with the aim of checking the accuracy, dimensional stability, and reliability of orthodontic retainers made on a conventional and digitally fabricated model over a six-month period after debonding. Material and methods The patients were selected from those who have completed fixed orthodontic mechanotherapy from the Department of Orthodontics and Dentofacial Orthopaedics, Sri Guru Ram Das Institute of Dental Sciences and Research, Sri Amritsar. Fifty patients received a clear retainer, which was fabricated for the upper and lower arch after removing the brackets. Patients were included in this study irrespective of their age groups. The manual method used a vacuum-forming machine to fabricate six retainers on stone models. In the digital method, new impressions were taken after three months, and digital models were obtained through 3D scanning and printing, followed by clear retainer fabrication. The data were gathered through a systematic process involving manual and digital methods for clear retainer fabrication and subsequent evaluation. The data obtained was computed for statistical evaluation and comparison. Results Mean and standard deviations of conventional (manual) and digital variables in the two groups were calculated. An ANOVA test was used to evaluate statistically significant differences for mesiodistal width and buccolingual width, and a post hoc Tuckey test was applied for multiple comparisons. The results indicated that most mesiodistal and buccolingual width measurements showed non-significant variations and exhibited a good correlation. Extraction space opening, assessed through an independent t-test for both the maxilla and mandible, also yielded non-significant and comparable results. Additionally, intra-operator and inter-operator measurements using a digital caliper demonstrated high agreement. Intra-class correlation (ICC) values exceeded 0.75, and inter-operator ICC results reflected a high level of agreement ranging from 0.8 to 0.99. Conclusion The primary objective of this study was to establish a correlation between the accuracy, dependability, and clinical efficacy of orthodontic retainers produced using both conventional and digitally created models. This investigation spanned a duration of six months following the removal of orthodontic brackets. The results showed that most of the statistically significant values were due to the inherent potential of the 3D printer for polymerization shrinkage, which, being a stereolithographic 3D printer, had a potential for a slight dimensional shift in the transverse dimension. However, the mean difference between all the models printed was slight and clinically insignificant.

Evaluation of Secondary and Late Secondary Alveolar Bone Grafting on 66 Unilateral Cleft Lip and Palate Patients.

OBJECTIVE: The aim of this retrospective study was to evaluate the outcomes of secondary alveolar bone grafting and late secondary alveolar bone grafting in 66 unilateral cleft lip and palate patients. MATERIALS AND METHODS: The total patients were 66 unilateral cleft lip and palate patients, out of which 19 patients underwent secondary alveolar bone grafting and 47 patients underwent late secondary alveolar bone grafting. Autogenous anterior iliac crest cancellous bone graft was harvested and used for grafting the alveolar clefts. Radiographic assessment based on Enemark's scoring according to the marginal bone levels was done on the intraoral periapical radiographs taken 6 months after performing the surgery. RESULTS: Twelve (63%) out of the 19 patients on whom secondary alveolar bone grafting was done achieved score 1 (optimal marginal bone levels), whereas only 12 (25%) out of the 47 patients achieved score 1 amongst the late secondary alveolar bone graftings. Overall results showed, probability, P = .034 (statistically significant). CONCLUSION: This study reaffirmed the fact that alveolar bone grafting when done in preadolescent age group (secondary alveolar bone grafting) gives better results in terms of marginal bony consolidation and maintaining the continuity of the alveolar arch, but the late presentation (late secondary alveolar bone grafting) should not be the refusal criteria for performing the alveolar bone grafting. Although the latter patients may not be rewarded in terms of bony consolidation as much as the preadolescent patients the potential of successful surgery in them still exists in terms of providing a platform for the dental implant placement, improvement in the soft tissue symmetry and aesthetics of the face.

OBJECTIF: La présente étude rétrospective visait à évaluer le résultat des alvéoloplasties secondaires et des alvéoloplasties secondaires tardives chez 66 patients ayant une fente labio-palatine unilatérale. MATÉRIEL ET MÉTHODOLOGIE: Au total, 66 patients ayant une fente labio-palatine unilatérale ont participé à l'étude, dont 19 ont subi une alvéoloplastie secondaire et 47, une alvéoloplastie secondaire tardive. Les plasticiens ont prélevé de l'os spongieux autologue au niveau de la crête iliaque pour le greffer dans la fente alvéolaire. Six mois après l'opération, ils ont attribué un score d'Enemark à la hauteur de l'os marginal d'après leur examen des radiographies périapicales intraorales. RÉSULTATS: Douze des 19 patients (63 %) qui avaient subi une alvéoloplastie secondaire ont obtenu un score de 1 (hauteur optimale de l'os marginal), par rapport à seulement 12 des 47 patients (25 %) qui avaient subi une alvéoloplastie secondaire tardive. Les résultats globaux ont démontré une probabilité p=0,034 (statistiquement significative). CONCLUSION: La présente étude confirme que l'alvéoloplastie réalisée chez des préadolescents (alvéoloplastie secondaire) assure une meilleure consolidation osseuse marginale et la continuité de l'arc alvéolaire, mais une présentation tardive (alvéoloplastie secondaire tardive) ne devrait pas constituer un critère pour refuser l'alvéoloplastie. Même si les patients plus âgés ne profitent pas d'une aussi bonne consolidation osseuse que les préadolescents, il se peut tout de même que l'opération leur fournisse la plateforme nécessaire pour installer l'implant dentaire, améliorer la symétrie des tissus mous et l'esthétisme du visage.

The Soft Palate Friendly Speech Bulb for Velopharyngeal Insufficiency.

Velopharyngeal insufficiency is an anatomic defect of the soft palate making palatopharyngeal sphincter incomplete. It is an important concern to address in patients with bilateral cleft lip and palate. Speech aid prosthesis or speech bulbs are best choice in cases where surgically repaired soft palate is too short to contact pharyngeal walls during function but these prosthesis have been associated with inadequate marginal closure, ulcerations and patient discomfort. Here is a case report of untreated bilateral cleft lip and palate associated with palatal insufficiency treated by means of palate friendly innovative speech bulb. This modified speech bulb is a combination of hard acrylic and soft lining material. The hard self-curing acrylic resin covers only the hard palate area and a permanent soft silicone lining material covering the soft palate area. A claw-shaped wire component was extended backwards from acrylic and was embedded in soft silicone to aid in retention and approximation of two materials. The advantage of adding the soft lining material in posterior area helped in covering the adequate superior extension and margins for maximal pharyngeal activity. This also improved the hypernasality, speech, comfort and overall patient acceptance.

Diagonal tooth measurements in sex assessment: A study on North Indian population.

BACKGROUND: Sexual dimorphism has been of great interest to anthropologists and odontologists. Dental measurements are important in anthropology for the study of sexual dimorphism with most common being the traditional linear odontometric measurements. Apart from these, alternative dental measurements have been developed such as the crown and cervical diagonal diameters and mesiodistal and buccolingual cervical diameters of teeth. AIMS AND OBJECTIVE: The primary objective of the following study is to assess the degree of sexual dimorphism in teeth of a North Indian population using the crown diagonal diameters and secondary is to evaluate the applicability of diagonal measurements in sex determination by means of discriminant functional analysis. MATERIALS AND METHODS: The study sample comprised 200 individuals (100 males and 100 females) of an age group ranging from 18 to 57 years, in a North Indian population. The mesiobuccal-distolingual (MBDL) and distobuccal-mesiolingual (DBML) crown diameters of seven maxillary and seven mandibular teeth on the study models were measured using digital Vernier calipers. RESULTS: The most dimorphic teeth amongst all for crown diagonal diameters are the maxillary central incisors and the least dimorphic are the maxillary second premolars. The mean diagonal crown dimensions in all but one tooth (DBML of maxillary lateral incisor) of males exceeded that of females. The difference was statistically significant in MBDL dimensions of maxillary and mandibular central incisor, canine, first and second molar and DBML dimensions of maxillary central incisor and maxillary and mandibular canine, first molar and second molar (P < 0.05). The accuracy of determination of sex by MBDL crown dimension ranges from 55% to 75% in males and 47-84% in females, while by DBML crown dimension ranges from 55% to 80% in males and 65-80% in females with the overall accuracy of sex determination ranging from 51% to 80% respectively. CONCLUSION: MBDL and DBML crown dimensions are reliable indicators and can be used along with or/and instead of linear measurements in sex determination. In situations in which it is difficult to take correct measurements of linear dimensions of teeth, these alternative odontometric measurements can be used consistently to determine sex.

Cellular telephone as reservoir of bacterial contamination: myth or fact.

OBJECTIVE: To assess bacterial contamination of cellular telephone of dental care personnel, and to determine factors contributing to their contamination. MATERIALS AND METHODS: A descriptive, cross-sectional study was conducted, which included 300 people using a cellular telephone The study group (hundred in each group) comprised of Dental Health Care Personnel (DHCP), In-Hospital Personnel (IHP) and Out-Hospital Personnel (OHP) of a dental college cum hospital. Swab was wiped along the front and all sides of cellular handset and it was incubated in glucose broth. The swab was subplated onto growth media plates made with half Mac Conkey's agar and half blood agar and allowed to incubate for 48 hours at 37(o)C. Isolates were tested for antimicrobial susceptibility. RESULT: The analysis of presence or absence of microorganisms in the DHCP, IHP and OHP group showed no pyogenic growth in 28%, 31% and 41% cases respectively, the distribution of which was not significant (p>.05). Among non potential pathogens, spore bearing gram positive bacilli were seen in 20 cases of DHCP group, 16 cases of IHP group and 17 cases of OHP group; the distribution of which was not significant (p>.05) Among potential pathogens, significant differences were observed in the distribution of growth of Enterobacter (p<.001), Pseudomonas species (p<.05), Acinetobacter bacteria (p<.05) and Methicillin-resistant Staphylococcus aureus (MRSA) bacteria (p<.001) between the participants of different groups. CONCLUSION: RESULTs of this study showed that fomites such as cellular telephones can potentially act as "Trojan horses", thus causing Hospital-Acquired Infections (HAIs) in the dental setting.