Are braces effective for patients with unilateral cleft palate undergoing alveolar bone graft surgery?

Recruiting

• Conditions: Cleft hard palate,

• Registration Number: CTRI/2020/10/028756
• Lead Sponsor: Badri Thiruvenkatachari

Brief Summary

The study is a parallel group prospective randomized controlled trial to compare the effectiveness of pre graft orthodontic treatment against no orthodontic treatment controls, a single blinded multi- centered study on 36 cleft patients divided randomly (computer generated) with three centres in India. The primary outcome would be the effectiveness of pre bone alveolar bone graft orthodontic treatment for Children with cleft palate, by the success of alveolar bone graft assessed from CBCT and Lateral oblique (Kindelan method). The secondary outcomes are Quality of the Dento-occlusal outcome measured on study models, Qualitative assessment using the validated quality of life questionnaires Breakages and cost efficiency a longitudinal study. Data analysis will be carried out at the end of the trial and will be on an intention-to-treat basis. The continuous outcomes will be analysed using mean and 95% CI and dichotomous data will be analysed using Chi-squared test  and effect estimates reported using relative risks and 95% confidence intervals.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-11
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Unilateral cleft alveolus requiring alveolar bone graft.
• Upper central incisors erupted.
• Written informed consent.
• One care/parent must be a native language speaker of the state of residence.

Exclusion Criteria

Bilateral Cleft palate Patients with syndromes or other medical condition Subjects involved in any other orthodontic trials Inadequate oral hygiene.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success of alveolar bone graft assessed from	Oblique occlusal: baseline (T1), Pregraft (T3), 3 months post surgery (T4)and six months post surgery (T5) | CBCT: six months post surgery (t%)
oblique occlusal (Kindelan method) and	Oblique occlusal: baseline (T1), Pregraft (T3), 3 months post surgery (T4)and six months post surgery (T5) | CBCT: six months post surgery (t%)
CBCT	Oblique occlusal: baseline (T1), Pregraft (T3), 3 months post surgery (T4)and six months post surgery (T5) | CBCT: six months post surgery (t%)

Secondary Outcome Measures

Name	Time	Method
Quality of the dento-occlusal outcome measured on study models using 10 year old index scores	Six months post surgery (T5)
Qualitative assessment using the validated quality of life questionnaires	All time points T1-T6
Quality adjusted cost analysis

Trial Locations

Locations (3)

Sant Parmanand Hospital, Delhi; 🇮🇳 Delhi, DELHI, India

Sree Balaji Dental College & Hospital, Bharath Institute of Higher Education and Research (BIHER; 🇮🇳 Chennai, TAMIL NADU, India

Sri Ramachandra Dental College ,Sri Ramachandra Institute of Higher Education and Research; 🇮🇳 Chennai, TAMIL NADU, India

Sant Parmanand Hospital, Delhi

🇮🇳Delhi, DELHI, India

Dr Puneet Batra

Principal investigator

9810335961

drpuneetbatra@gmail.com