CORE OUTCOME SETS AND DENTAL PATIENT REPORTED OUTCOMES.

In clinical research, outcomes are the results or 'endpoints' that are measured to assess whether clinical interventions have been successful or whether one treatment works better than another. There are a vast number of outcomes that have been reported in dental trials; the number, diversity and questionable relevance of these outcomes can lead to research wastage. Ultimately, this can lead to uncertainty for patients and dental professionals as to the most effective prevention and treatment options available as the evidence available may not use outcomes important to them. This article introduces the reader to core outcome sets (COS), covering the background to this area of research; their purpose and role; as well as the methodology of development. The authors reflect on their experience of leading the development of a core outcome set for periodontal trials and we highlight other dental COSs already developed and their inclusion of dental Patient Reported Outcomes (dPROs).

Developing a core outcome set for periodontal trials.

BACKGROUND: There is no agreement which outcomes should be measured when investigating interventions for periodontal diseases. It is difficult to compare or combine studies with different outcomes; resulting in research wastage and uncertainty for patients and healthcare professionals. OBJECTIVE: Develop a core outcome set (COS) relevant to key stakeholders for use in effectiveness trials investigating prevention and management of periodontal diseases. METHODS: Mixed method study involving literature review; online Delphi Study; and face-to-face consensus meeting. PARTICIPANTS: Key stakeholders: patients, dentists, hygienist/therapists, periodontists, researchers. RESULTS: The literature review identified 37 unique outcomes. Delphi round 1: 20 patients and 51 dental professional and researchers prioritised 25 and suggested an additional 11 outcomes. Delphi round 2: from the resulting 36 outcomes, 13 patients and 39 dental professionals and researchers prioritised 22 outcomes. A face-to-face consensus meeting was hosted in Dundee, Scotland by an independent chair. Eight patients and six dental professional and researchers participated. The final COS contains: Probing depths, Quality of life, Quantified levels of gingivitis, Quantified levels of plaque, Tooth loss. CONCLUSIONS: Implementation of this COS will ensure the results of future effectiveness trials for periodontal diseases are more relevant to patients and dental professionals, reducing research wastage. This could reduce uncertainty for patients and dental professionals by ensuring the evidence used to inform their choices is meaningful to them. It could also strengthen the quality and certainty of the evidence about the relative effectiveness of interventions. REGISTRATION: COMET Database: http://www.comet-initiative.org/studies/details/265?result=true.

A comparison of techniques for the explantation of osseointegrated dental implants.

Data sources A search of electronic databases (Embase and PubMed) was carried out along with manual and grey searches of published and unpublished journals. Publication year was from first available until 23 August 2018.Study selection Titles and abstracts from the original search were reviewed by two authors. Studies were chosen for full-text analysis and data extraction after inter-reviewer agreement. Disagreement was resolved by discussion and Cohen's kappa was used to measure inter-reviewer agreement. An initial search gave 2,197 articles and, following screening, 18 publications were included in the study. Five articles were case series and ten were case reports describing one to nine cases. Three publications reported on comparatively large sample sizes, one prospectively and two retrospectively. None of the studies had control groups or blinding. The QUADAS-2 tool was used for quality assessment. Studies were deemed to have high, low or unclear levels of bias by two examiners. All were considered high risk of bias. Publications included fulfilled the following criteria: English language, human studies, endosseous osseointegrated dental implants, explantation technique described and reason for explantation clearly reported.Data extraction and synthesis Data extraction followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline process. Studies chosen for analysis were examined and the following data parameters were included: study design, number of patients, number of implants removed, implant system, reason for explantation, explantation technique and its success or failure, complications, flap access, socket grafting and immediate implant placement.Results The following five techniques for explantation of dental implants were identified: reverse torque, trephines, piezosurgery, burs and laser-assisted explantation. Reverse torque was the most commonly described technique (284 implants) with 87.7% success. Burs were used to remove 49 implants with 100% success, while trephines were used for explantation of 35 implants with 94% success. Piezosurgery and Er, Cr: YSGG laser removed 11 implants and one implant, respectively, with 100% success. One study reported perforation of the maxillary sinus floor following the use of a trephine technique, while another reported the fracture of three implants using reverse torque. The quality of the studies and lack of available data prevented further analysis. Results were presented in a narrative format.Conclusion The authors recommend reverse torque as the first choice for explantation. Despite its inferior success rate, it is the most conservative technique in terms of bone removal and flap access, meaning there is a greater opportunity for immediate implant placement.

Do viruses play a role in peri-implantitis?

Data sources A search of electronic databases (EMBASE, MEDLINE, Cochrane Oral Group Trials Register and the Cochrane Central Register of Controlled Trials) along with a manual search of various Science Citation Indexed journals.Study selection Four cross-sectional studies and one case-control study were included where percentage levels of Herpes Simplex Virus Type 1 (HSV1), Epstein-Barr Virus (EBV) and Cytomegalovirus (CMV) were sampled for in both peri-implantitis affected and healthy implant sites, with the latter used as the control. Studies were excluded that investigated any other infective agent, had fewer than ten participants, was performed in vitro or involved subjects with only periodontal disease.Data extraction and synthesis Data extraction followed the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guideline process. Two examiners used the Newcastle Ottawa Scale to determine overall study quality while the key information was extracted and tabulated for comparison. The data was analysed using Chi-squared test and I2 test for heterogenicity with a random effects or fixed affect models applied as appropriate. Risk difference of outcomes was displayed via a forest plot with 95% confidence intervals. Funnel plots were generated to evaluate publication bias.Results All four cross-sectional studies searched for EBV, while three also looked for CMV. The case-control study included investigated for HSV1 presence only. EBV presence in peri-implantitis sites was found to be statistically significant in three of the four studies despite obvious heterogeneity. CMV presence at peri-implantitis sites was statistically significant in all relevant studies, but the data displayed notable heterogeneity so as to render it insignificant. HSV1 exhibited similar percentage frequency in both healthy and diseased implant sites.Conclusions Virus prevalence was found to be increased in patients with peri-implantitis when compared to healthy sites but this assertion must be treated with caution as the data supporting it is weak due to the limited number of studies involved and the significant inherent heterogeneity they displayed.

Improving the Quality of Dentistry (IQuaD): a cluster factorial randomised controlled trial comparing the effectiveness and cost-benefit of oral hygiene advice and/or periodontal instrumentation with routine care for the prevention and management of periodontal disease in dentate adults attending dental primary care.

BACKGROUND: Periodontal disease is preventable but remains the most common oral disease worldwide, with major health and economic implications. Stakeholders lack reliable evidence of the relative clinical effectiveness and cost-effectiveness of different types of oral hygiene advice (OHA) and the optimal frequency of periodontal instrumentation (PI). OBJECTIVES: To test clinical effectiveness and assess the economic value of the following strategies: personalised OHA versus routine OHA, 12-monthly PI (scale and polish) compared with 6-monthly PI, and no PI compared with 6-monthly PI. DESIGN: Multicentre, pragmatic split-plot, randomised open trial with a cluster factorial design and blinded outcome evaluation with 3 years' follow-up and a within-trial cost-benefit analysis. NHS and participant costs were combined with benefits [willingness to pay (WTP)] estimated from a discrete choice experiment (DCE). SETTING: UK dental practices. PARTICIPANTS: Adult dentate NHS patients, regular attenders, with Basic Periodontal Examination (BPE) scores of 0, 1, 2 or 3. INTERVENTION: Practices were randomised to provide routine or personalised OHA. Within each practice, participants were randomised to the following groups: no PI, 12-monthly PI or 6-monthly PI (current practice). MAIN OUTCOME MEASURES: Clinical - gingival inflammation/bleeding on probing at the gingival margin (3 years). Patient - oral hygiene self-efficacy (3 years). Economic - net benefits (mean WTP minus mean costs). RESULTS: A total of 63 dental practices and 1877 participants were recruited. The mean number of teeth and percentage of bleeding sites was 24 and 33%, respectively. Two-thirds of participants had BPE scores of ≤ 2. Under intention-to-treat analysis, there was no evidence of a difference in gingival inflammation/bleeding between the 6-monthly PI group and the no-PI group [difference 0.87%, 95% confidence interval (CI) -1.6% to 3.3%; p = 0.481] or between the 6-monthly PI group and the 12-monthly PI group (difference 0.11%, 95% CI -2.3% to 2.5%; p = 0.929). There was also no evidence of a difference between personalised and routine OHA (difference -2.5%, 95% CI -8.3% to 3.3%; p = 0.393). There was no evidence of a difference in self-efficacy between the 6-monthly PI group and the no-PI group (difference -0.028, 95% CI -0.119 to 0.063; p = 0.543) and no evidence of a clinically important difference between the 6-monthly PI group and the 12-monthly PI group (difference -0.097, 95% CI -0.188 to -0.006; p = 0.037). Compared with standard care, no PI with personalised OHA had the greatest cost savings: NHS perspective -£15 (95% CI -£34 to £4) and participant perspective -£64 (95% CI -£112 to -£16). The DCE shows that the general population value these services greatly. Personalised OHA with 6-monthly PI had the greatest incremental net benefit [£48 (95% CI £22 to £74)]. Sensitivity analyses did not change conclusions. LIMITATIONS: Being a pragmatic trial, we did not deny PIs to the no-PI group; there was clear separation in the mean number of PIs between groups. CONCLUSIONS: There was no additional benefit from scheduling 6-monthly or 12-monthly PIs over not providing this treatment unless desired or recommended, and no difference between OHA delivery for gingival inflammation/bleeding and patient-centred outcomes. However, participants valued, and were willing to pay for, both interventions, with greater financial value placed on PI than on OHA. FUTURE WORK: Assess the clinical effectiveness and cost-effectiveness of providing multifaceted periodontal care packages in primary dental care for those with periodontitis. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56465715. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 38. See the NIHR Journals Library website for further project information.

Core outcomes in periodontal trials: study protocol for core outcome set development.

BACKGROUND: There are a large number of clinical outcome measures used to assess the effectiveness of prevention and management strategies of periodontal diseases. This heterogeneity causes difficulties when trying to synthesise data for systematic reviews or clinical guidelines, reducing their impact. Core outcome sets are an agreed, standardised list of outcomes that should be measured and reported in all trials in specific clinical areas. We aim to develop a core outcome set for effectiveness trials investigating the prevention and management of periodontal disease in primary or secondary care. METHODS: To identify existing outcomes we screened the Cochrane systematic reviews and their included studies on the prevention and management of periodontal diseases. The core outcome set will be defined by consensus of key stakeholders using an online e-Delphi process and face-to-face meeting. Key stakeholders involved in the development will include: patients, dentists, hygienists/therapists, specialists, clinical researchers and policy-makers. Stakeholders will be asked to prioritise outcomes and feedback will be provided in the next round(s). Stakeholders will have an opportunity to add outcomes found in the Cochrane review screening process at the end of the first round. If consensus is not reached after the second round we will provide feedback prior to a third round. Remaining outcomes will be discussed at a face-to-face meeting and agreement will be measured via defined consensus rules of outcome inclusion. DISCUSSION: The inclusive consensus process should provide a core outcome set that is relevant to all key stakeholders. We will actively disseminate our findings to help improve clinical trials, systematic reviews and clinical guidelines with the ultimate aim of improving the prevention and management of periodontal diseases. TRIAL REGISTRATION: COMET ( http://www.comet-initiative.org/studies/details/265?result=true ). Registered on August 2012.

IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care.

BACKGROUND: Periodontal disease is the most common oral disease affecting adults, and although it is largely preventable it remains the major cause of poor oral health worldwide. Accumulation of microbial dental plaque is the primary aetiological factor for both periodontal disease and caries. Effective self-care (tooth brushing and interdental aids) for plaque control and removal of risk factors such as calculus, which can only be removed by periodontal instrumentation (PI), are considered necessary to prevent and treat periodontal disease thereby maintaining periodontal health. Despite evidence of an association between sustained, good oral hygiene and a low incidence of periodontal disease and caries in adults there is a lack of strong and reliable evidence to inform clinicians of the relative effectiveness (if any) of different types of Oral Hygiene Advice (OHA). The evidence to inform clinicians of the effectiveness and optimal frequency of PI is also mixed. There is therefore an urgent need to assess the relative effectiveness of OHA and PI in a robust, sufficiently powered randomised controlled trial (RCT) in primary dental care. METHODS/DESIGN: This is a 5 year multi-centre, randomised, open trial with blinded outcome evaluation based in dental primary care in Scotland and the North East of England. Practitioners will recruit 1860 adult patients, with periodontal health, gingivitis or moderate periodontitis (Basic Periodontal Examination Score 0-3). Dental practices will be cluster randomised to provide routine OHA or Personalised OHA. To test the effects of PI each individual patient participant will be randomised to one of three groups: no PI, 6 monthly PI (current practice), or 12 monthly PI.Baseline measures and outcome data (during a three year follow-up) will be assessed through clinical examination, patient questionnaires and NHS databases.The primary outcome measures at 3 year follow up are gingival inflammation/bleeding on probing at the gingival margin; oral hygiene self-efficacy and net benefits. DISCUSSION: IQuaD will provide evidence for the most clinically-effective and cost-effective approach to managing periodontal disease in dentate adults in Primary Care. This will support general dental practitioners and patients in treatment decision making. TRIAL REGISTRATION: Protocol ID: ISRCTN56465715.