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CTRI Number  CTRI/2017/08/009331 [Registered on: 10/08/2017] Trial Registered Retrospectively
Last Modified On: 24/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the efficiency of limited bone injury in increasing the rate of tooth movement during orthodontic treatment. 
Scientific Title of Study   Efficiency of micro-osteoperforation assisted orthodontics on the rate of canine retraction: a split mouth randomized controlled clinical trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
17057  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivani Singh 
Designation  Assistant Professor 
Affiliation  Manipal University 
Address  Department of Orthodontics, Room No.6, Manipal College of Dental Sciences, Light House Hill Road, Kasturba Medical College, Mangalore, India.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  08242428716  
Fax  08242428716  
Email  emailshivanisingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shivani Singh 
Designation  Assistant Professor 
Affiliation  Manipal University 
Address  Department of Orthodontics, Room No.6, Manipal College of Dental Sciences, Light House Hill Road, Kasturba Medical College, Mangalore, India.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  08242428716  
Fax  08242428716  
Email  emailshivanisingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shivani Singh 
Designation  Assistant Professor 
Affiliation  Manipal University 
Address  Department of Orthodontics, Room No.6, Manipal College of Dental Sciences, Light House Hill Road, Kasturba Medical College, Mangalore, India.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  08242428716  
Fax  08242428716  
Email  emailshivanisingh@gmail.com  
 
Source of Monetary or Material Support  
Department of Orthodontics, Manipal College Of Dental Sciences, Mangalore. 
 
Primary Sponsor  
Name  Dr Shivani Singh 
Address  Room no. 6, Department of Orthodontics, Manipal College of Dental Sciences, Manipal University, Light House Hill Road, Mangalore, Karnataka, India. 575001. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivani Singh  Manipal College of Dental Sciences.  Room no 6, Department of Orthodontics, Light House Hill Road, Mangalore. 575001.
Dakshina Kannada
KARNATAKA 		 8880984538
0824-2422271
emailshivanisingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MCODS, Mangalore.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Dental malocclusion, forwardly placed upper front teeth. 
Patients  Proclined upper incisors.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Micro-osteoperforations (MOPs)  Total of 6 MOPs, placed in two rows of four MOPs each, 3 mm apart, first row of three MOPs placed 2 mm distal to canine root and starting from 4 mm below the alveolar crest, while second row placed at 4 mm from distal root of canine. 
Comparator Agent  No intervention.  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  32.00 Year(s)
Gender  Both 
Details  1. Patients undergoing fixed mechanotherapy with upper first premolar extractions requiring 5 mm or more of maxillary canine retraction.
2. Presence of full complement of teeth except third molars.
3. Fair oral hygiene.
 
 
ExclusionCriteria 
Details  Patients presenting with:
1. Previous history of orthodontic treatment.
2. Medical or systemic problems.
3. Active caries, pulpitis or periodontal disease.
4. Severe crowding (≥6mm) or severe cant of the maxillary skeletal base or palatal plane (inclination angle ≤ 80 and ≥ 95 degrees and base plane angle ≤20 and ≥40 degrees) simultaneously existing with severely divergent or convergent facial planes (Bjork sum <385 and >400).
5. Patients exhibiting microdontia or less than 5 mm of space available for canine retraction.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean rate of canine retraction per month, until 2 mm or less space is present distal to canine. Measured intraorally using a digital calipers. Measured as: residual extraction space between lateral incisor (disto-gingival wing of the bracket) and canine (mesio-gingival wing of the bracket); in mm; then expressed as [(space T0-space T1)/time T0-to-T1] in mm/month. Measured by: a calibrated person, fully blinded to experimental/control side (an orthodontist).   Measurement timing: at baseline (before space closure), at 1-month intervals; end at space closure finalization (2 mm or less space remaining distal to the canine). 
 
Secondary Outcome  
Outcome  TimePoints 
•Cumulative canine distal movement measured in mm, on pre and post dental casts.
• Canine and molar rotation, tip, root resorption,bone density in HU, and alveolar bone loss to be measured on CBCT scans.
• Any scars from MOPs, tooth discoloration, devitalisation or gingiva invagination will be noted.
Discomfort level on VAS scale. 		 At T0 and Tfinal, except,
discomfort level which will be measured daily after the intervention for a week. 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   05/07/2017 
Date of Study Completion (India) 13/10/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 none 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is an in vivo, interventional, surgical, single-center, split-mouth randomized, controlled clinical trial evaluating the efficiency of micro-osteoperforations in enhancing the rate of canine retraction and its effects on various dental and bony structures.
The primary outcome measure will be the mean rate of canine retraction per month, which will be measured intraorally.
The hypotheses are:
1. There is no difference in the rate of micro-osteoperforation assisted and conventional canine retraction.
2. There is no difference in the amount of anchorage loss, cumulative canine displacement, root resorption, alveolar bone loss, bone density and discomfort level between micro-osteoperforation and conventional canine retraction.
 
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