Development of a core outcome set for orthodontic trials using a mixed-methods approach: Protocol for a multicentre study

© 2017 The Author(s). Background: Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider what patients truly feel about, or want, from treatment, and a diverse range of outcomes is being used with little consistency between studies. This study aims to address these problems, using established methodology to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people. Methods/design: This is a mixed-methods study incorporating four distinct stages. The first stage will include a scoping review of the scientific literature to identify primary and secondary outcome measures that have been used in previous orthodontic clinical trials. The second stage will involve qualitative interviews and focus groups with orthodontic patients aged 10 to 16 years to determine what outcomes are important to them. The outcomes elicited from these two stages will inform the third stage of the study in which a long-list of outcomes will be ranked in terms of importance using electronic Delphi surveys involving clinicians and patients. The final stage of the study will involve face-to-face consensus meetings with all stakeholders to discuss and agree on the outcome measures that should be included in the final core outcome set. Discussion: This research will help to inform patients, parents, clinicians and commissioners about outcomes that are important to young people undergoing orthodontic treatment. Adoption of the core outcome set in future clinical trials of orthodontic treatment will make it easier for results to be compared, contrasted and combined. This should translate into improved decision-making by all stakeholders involved. Trial registration: The project has been registered on the Core Outcome Measures in Effectiveness Trials (COMET) website, January 2016

What is the value of orthodontic treatment?

Orthodontic treatment is as popular as ever. Orthodontists frequently have long lists of people wanting treatment and the cost to the NHS in England was £258m in 2010-2011 (approximately 10% of the NHS annual spend on dentistry). It is important that clinicians and healthcare commissioners constantly question the contribution of interventions towards improving the health of the population. In this article, the authors outline some of the evidence for and against the claims that people with a malocclusion are at a disadvantage compared with those without a malocclusion and that orthodontic treatment has significant health benefits. The authors would like to point out that this is not a comprehensive and systematic review of the entire scientific literature. Rather the evidence is presented in order to stimulate discussion and debate

Dental antibiotic policies, stewardship, and implementation in India: A policy document analysis

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

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)

Do malocclusion and orthodontic treatment impact oral health?:A systematic review and meta-analysis

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.</p