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CTRI Number  CTRI/2020/10/028756 [Registered on: 29/10/2020] Trial Registered Prospectively
Last Modified On: 31/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Other (Specify) [Orthodontics]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Are braces effective for patients with unilateral cleft palate undergoing alveolar bone graft surgery?  
Scientific Title of Study   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) 
Trial Acronym  PABO 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Badri Thiruvenkatachari 
Designation  Professor in Orthodontics and Director, Dental Research 
Affiliation  Sree Balaji Dental College and Hospital 
Address  Sree Balaji Dental College and Hospital, Department of Orthodontics and Dentofacial Orthopaedics, Cleft and Craniofacial division, Second floor.

Chennai
TAMIL NADU
600100
India 
Phone  00917358483837  
Fax    
Email  badri.t.chari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Badri Thiruvenkatachari 
Designation  Professor in Orthodontics and Director, Dental Research 
Affiliation  Sree Balaji Dental College and Hospital 
Address  Sree Balaji Dental College and Hospital, Department of Orthodontics and Dentofacial Orthopaedics, Cleft and Craniofacial division, Second floor.

Chennai
TAMIL NADU
600100
India 
Phone  00917358483837  
Fax    
Email  badri.t.chari@gmail.com  
 
Details of Contact Person
Public Query  
Name  Badri Thiruvenkatachari 
Designation  Professor in Orthodontics and Director, Dental Research 
Affiliation  Sree Balaji Dental College and Hospital 
Address  Sree Balaji Dental College and Hospital, Department of Orthodontics and Dentofacial Orthopaedics, Cleft and Craniofacial division, Second floor.

Chennai
TAMIL NADU
600100
India 
Phone  8667342684  
Fax    
Email  badri.t.chari@gmail.com  
 
Source of Monetary or Material Support  
Sant Parmanand Hospital, Delhi 
SERB - Core research Grant 
Sree Balaji Dental College & Hospital, Bharath Institute of Higher Education and Research (BIHER) 
Sri Ramachandra Dental College Sri Ramachandra Institute of Higher Education and Research 
 
Primary Sponsor  
Name  Badri Thiruvenkatachari 
Address  Director, Dental Research Sree Balaji Dental College and Hospital Bharath Institute of Higher Education and Research Chennai, Tamil Nadu India.  
Type of Sponsor  Other [Individual] 
 
Details of Secondary Sponsor  
Name  Address 
Bharath Institue of Higher Education and Research  Velachery Main Rd, VGP Rajesh Nagar, Pallikaranai, Chennai, Tamil Nadu 600100.  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Puneet Batra  Sant Parmanand Hospital, Delhi  Dental Wing, Cleft and Craniofacial division 18, Sham Nath Marg, Civil Lines, New Delhi, Delhi 110054
New Delhi
DELHI 		 9810335961

drpuneetbatra@gmail.com 
Dr Badri Thiruvenkatachari  Sree Balaji Dental College & Hospital, Bharath Institute of Higher Education and Research (BIHER  Department of Orthodontics and Dentofacial Orthopaedics, Cleft and Craniofacial division, Second floor. Velachery Main Rd, VGP Rajesh Nagar, Pallikaranai, Chennai, Tamil Nadu 600100.
Chennai
TAMIL NADU 		 00917358483837

badri.t.chari@gmail.com 
Dr Altaf Hussain  Sri Ramachandra Dental College ,Sri Ramachandra Institute of Higher Education and Research  Department of Plastic and Reconstructive Surgery, Cleft and Craniofacial Division, No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116.
Chennai
TAMIL NADU 		 9600063199

syedaltafhussain@sriramachandra.edu.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Comitee, Sree Balaji Dental College and hospital (BIHER)  Approved 
Institutional Ethics Comitee, Sri Ramachandra Institute of Higher Education and Research  Submittted/Under Review 
Institutional Ethics Comitee,Institute of Dental Studies and Technologies Delhi, India  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q351||Cleft hard palate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  no intervention/no orthodontic treatment  No orthodontic treatment and pre-graft orthodontics for a period of 2 years 
Intervention  Orthodontic treatment  Orthodontic treatment with pre-alveolar bone graft for a period of two years  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  Bilateral Cleft palate
Patients with syndromes or other medical condition
Subjects involved in any other orthodontic trials
Inadequate oral hygiene
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Success of alveolar bone graft assessed from
oblique occlusal (Kindelan method) and
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  
Outcome  TimePoints 
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
 		 All time points T1-T6 
 
Target Sample Size
Modification(s)  		 Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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. 

 
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