| CTRI Number |
CTRI/2018/06/014361 [Registered on: 01/06/2018] Trial Registered Prospectively |
| Last Modified On: |
28/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY TO COMPARE THETOOTH MOVEMENTS WITH MICRO OSTEOPERFORATION AT SINGLE SITE VERSUS THAT AT MULTIPLE SITE |
|
Scientific Title of Study
|
A COMPARATIVE PROSPECTIVE CLINICAL STUDY TO EVALUATE THE RATE OF ANTERIOR EN MASSE RETRACTION WITH MICRO OSTEOPERFORATION(MOP) AT SINGLE SITE VERSUS THAT AT MULTIPLE SITES. |
| Trial Acronym |
MOP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Demelta Nobert |
| Designation |
Post graduate student in orthodontics |
| Affiliation |
Sri Hasanamba Dental College And Hospital |
| Address |
Department of orthodontics and dentofacial orthopaedics,
Sri Hasanamba dental college and hospital, Hassan , Karnataka
Department of orthodontics and dentofacial orthopaedics,
Sri Hasanamba dental college and hospital, Hassan , Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
8304871030 |
| Fax |
|
| Email |
demeltad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CHETAN S |
| Designation |
READER OF THE DEPARTMENT |
| Affiliation |
Sri Hasanamba Dental College And Hospital |
| Address |
Sri Hasanamba dental college and hospital,
Department of orthodontics and dentofacial orthopaedics,ROOM NO 7, Hassan , Karnataka
Sri Hasanamba dental college and hospital,
Department of orthodontics and dentofacial orthopaedics,ROOM NO 7, Hassan , Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
|
| Fax |
|
| Email |
shankar_chetan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr CHETAN S |
| Designation |
READER OF THE DEPARTMENT |
| Affiliation |
Sri Hasanamba Dental College And Hospital |
| Address |
Department of orthodontics and dentofacial orthopaedics, Sri Hasanamba dental college and hospital, Hassan , Karnataka
Sri Hasanamba dental college and hospital,
Department of orthodontics and dentofacial orthopaedics,ROOM NO 7, Hassan , Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
|
| Fax |
|
| Email |
shankar_chetan@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL,HASSAN,KARNATAKA |
|
|
Primary Sponsor
|
| Name |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
| Address |
VIDYANAGAR,HASSAN,KARNATAKA
573201 |
| 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 |
| DEMELTA NOBERT |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, ROOM NUMBER :7
Hassan
KARNATAKA |
8304871030
demeltad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
TOOTH MALALIGNMENT, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MICRO OSTEOPERFORATION |
MICRO OSTEOPERFORATION AS SPEEDY ORTHODONTIC PROCEDURE FOR EN MASSE RETRACTION |
| Comparator Agent |
NORMAL ORTHODONTIC TOOTH MOVEMENT |
MICRO OSTEOPERFORATION COMPARED WITH NORMAL ORTHODONTIC TOOTH MOVEMENT |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects in whom maxillary 1st premolar1. All subjects undergoing treatment with Pre-adjusted Edgewise appliance (PEA) with 0.022 MBT prescription
2. Subjects who have completed the leveling and alignment ( Ist phase)
3. Patients in whom maxillary first premolar extraction will be indicated for en masse
retraction of anteriors
4. Patients who will have a minimum of 5 mm of space available for en masse retraction of anteriors
5. Subjects in the age group of 18 - 30 years.
6. Subjects with average skeletal pattern.
|
|
| ExclusionCriteria |
| Details |
1. Previous history of orthodontic treatment.
2. Presence of any craniofacial anomalies.
3. Presence of any signs and symptoms of periodontal disease.
4. Long term use of phenytoin sodium, cyclosporin, anti-inflammatory drugs,
systemic corticosteroids and calcium channel blockers.
5. Poor oral hygiene for more than 2 visits.
6. Smoking, other habits such as chewing pan.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DECREASE IN TREATMENT DURATION |
FASTER TOOTH MOVEMENT
FASTER TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MEASUREMENT OF ANCHORAGE LOSS |
BASELINE 3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
21/06/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Over the recent years, as a result of the emphasis placed on facial esthetics, an increasing number of adults are reporting for orthodontic treatment. However there are still a large number of patients who are reluctant to seek orthodontic treatment because of the prolonged duration of treatment.Several methods have been proposed to accelerate orthodontic tooth movement and reduce the treatment time.Micro osteoperforation (MOP) is the currently available micro invasive option to accelerate orthodontic tooth movement. MOP can be completed chairside in minutes, and does not require any advanced training. Additionally the treatment yields little discomfort to the patient. There is zero recovery time, and the patients will be able to immediately return to their normal daily routine.Hence this prospective clinical trial is intended to compare the efficiency of MOPs performed at the extraction site; ie distal to canine with that of MOPs performed in the interdental bone of all the anterior teeth for anterior en mass retraction. |