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BackgroundThere 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.ObjectiveDevelop a core outcome set (COS) relevant to key stakeholders for use in effectiveness trials investigating prevention and management of periodontal diseases.MethodsMixed method study involving literature review; online Delphi Study; and face-to-face consensus meeting.ParticipantsKey stakeholders: patients, dentists, hygienist/therapists, periodontists, researchers.ResultsThe 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.ConclusionsImplementation 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.RegistrationCOMET Database: http://www.comet-initiative.org/studies/details/265?result=true.

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.

Abstract 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.