| CTRI Number |
CTRI/2017/08/009331 [Registered on: 10/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
21/03/2026 |
| 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
|
|
|
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
|
|
|
Regulatory Clearance Status from DCGI
|
|
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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/07/2017 |
| 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="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
trial terminated |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
terminated |