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).

Effectiveness of pre-alveolar bone graft orthodontics for patients with non-syndromic complete unilateral cleft lip, alveolus and palate: A systematic review and meta-analysis.

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.

A Survey on Alveolar Bone Grafting in Indian Cleft Centers.

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.

Reducing the burden of orthodontic care for children with clefts: evaluating the effectiveness of pre-alveolar bone graft orthodontics in unilateral non-syndromic cleft patients (PABO study)- A study protocol for a multicentric randomised controlled trial.

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. .

Prospective, multi-center study of the effectiveness of orthodontic/orthognathic surgery care in the United Kingdom.

INTRODUCTION: The aim of this study was to evaluate the effectiveness of orthodontic/orthognathic surgical care provided in the North West region of England. It was an observational, prospective cohort study at 13 maxillofacial clinics in the United Kingdom. METHODS: The 131 patients comprised 47 males (35.9%) and 84 females (64.1%), with an average age of 22.6 years. They received orthodontic/orthognathic treatment according to the normal protocols of the operators. They were then followed until all orthodontic treatment was completed. Final skeletal pattern, final peer assessment rating score, number of attendances, and duration of treatment were recorded. RESULTS: At the end of the 5-year study, 94 patients had completed treatment, and 71 had complete data. Data analysis showed that, overall, the treatments provided were effective in terms of skeletal and dental occlusal outcomes; the final mean peer assessment rating score was 10.58. However, treatment duration was longer than commonly expected, with a mean length of 32.8 months (SD,11.3). The outcome of treatment was influenced by only pretreatment skeletal discrepancy. CONCLUSIONS: This prospective investigation showed that orthodontic/orthognathic surgical care was effective. The outcome of treatment was influenced only by the severity of the pretreatment skeletal discrepancy.