| CTRI Number |
CTRI/2020/06/025640 [Registered on: 05/06/2020] Trial Registered Prospectively |
| Last Modified On: |
26/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Technique to increase tooth movement with braces |
|
Scientific Title of Study
|
Effect of micro-osteoperforations on the rate of orthodontic tooth movement-A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amol Patil |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Bharati Vidyapeeth Deemed to be UNiversity |
| Address |
Bharati vidyapeeth dental college and hospital, katraj
Pune
MAHARASHTRA
411043
India |
| Phone |
7774048166 |
| Fax |
|
| Email |
amolp66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amol Patil |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Bharati Vidyapeeth Deemed to be UNiversity |
| Address |
Bharati vidyapeeth dental college and hospital, katraj
Pune
MAHARASHTRA
411043
India |
| Phone |
7774048166 |
| Fax |
|
| Email |
amolp66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amol Patil |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Bharati Vidyapeeth Deemed to be UNiversity |
| Address |
Bharati vidyapeeth dental college and hospital, katraj
Pune
MAHARASHTRA
411043
India |
| Phone |
7774048166 |
| Fax |
|
| Email |
amolp66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dental college and Hospital, Bharati Vidyapeeth Deemed to be UNiversity, Pune |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed to be UNiversity |
| Address |
Dental college and Hospital, Bharati Vidyapeeth Deemed to be UNiversity, Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Amol Patil |
Bharati vidyapeeth dental college and hospital, katraj, Pune |
room no 314,PG section, Department of Orthodontics and dentofacial orthopedics
Pune
MAHARASHTRA |
7774048166
amolp66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dental College and Hospital, Pune,Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Angles Class I and Class II Bimaxillary protrusion cases |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Retraction without Microosteo perforation (MOP) |
| Intervention |
Micro-Osteo perforation group |
Each patient will receive micro-osteoperforations under topical local anesthesia on the mesial and distal side of each tooth from canine to canine in the maxillary and mandibular arch. T0 (1st set of MOPs), T1 (delivery of 2nd set of MOPs), T2 (after 2 months).T3( after 3 months )and T4( after 4 months) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Class I Bi-maxillary protrusion
Class II Bi-maxillary protrusion
No systemic disease
No radiographic evidence of bone loss
|
|
| ExclusionCriteria |
| Details |
-Long term use of antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers
-Poor oral hygiene for more than 2 visits
-Systemic disease
-Evidence of bone loss
-Past periodontal disease
-Current periodontal disease
-Smoking
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| rate of tooth movement |
at 3 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| rate of tooth movement |
at 1 month, 2 month and 3 months of tooth movement |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 1 |
|
Date of First Enrollment (India)
|
30/06/2020 |
| 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="0"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
- a)Sample size-(i) Experimental group-70 (b)Age Group -18-25yrs
(ii) Control group-70 - Two sets of records (alginate impression) will be collected at T0 and T4. T0 (at the start of en-masse retraction and delivery of 1st set of MOPs), T1 delivery of 2nd set of MOPs), T2 (after 2 months).T3( after 3 months )and T4( after 4 months, at the end of the study period)
Dental stone casts will be prepared from each impression. Linear measurements will be recorded on each cast using a digital caliper with an accuracy of 0.01 mm |