| CTRI Number |
CTRI/2024/09/074009 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study is to find out in which group of patients under braces treatment, the teeth moves fast when removal of teeth done before or during correction of crooked teeth. |
|
Scientific Title of Study
|
Comparative evaluation of rate of extraction space closure between early and delayed therapeutic 1st premolar extraction in bimaxillary protrusion patients using mini implants. A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohamed Shamsudeen |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital, Cuddalore |
| Address |
Department of Orthodontics,
Government Dental College and Hospital,cuddalore
erstwhile Rajah Muthiah Dental College and Hospital,Chidambaram
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9789089546 |
| Fax |
|
| Email |
drshamsudeen981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Kurunji kumaran |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and Hospital, Cuddalore |
| Address |
Department of Orthodontics,
Government Dental College and Hospital,cuddalore
erstwhile Rajah Muthiah Dental College and Hospital,Chidambaram
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
drkurinchi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Kurunji kumaran |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and Hospital, Cuddalore |
| Address |
Department of Orthodontics,
Government Dental College and Hospital,cuddalore
erstwhile Rajah Muthiah Dental College and Hospital,Chidambaram
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
drkurinchi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Cuddalore
Erstwhile Rajah Muthiah Dental college and hospital, chidambaram,cuddalore,Tamilnadu -608002
For infrastructure |
|
|
Primary Sponsor
|
| Name |
Dr Mohamed Shamsudeen A I |
| Address |
Department of orthodontics,
Government Dental College and Hospital, Cuddalore
Chidambaram-608002 |
| Type of Sponsor |
Other [(self funding)] |
|
|
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 Mohamed Shamsudeen A I |
Government Dental College and Hospital |
Department of Orthodontics,
Government Dental College and Hospital, Cuddalore,
(erstwhile Rajah Muthiah Dental College and Hospital, chidambaram
Cuddalore
TAMIL NADU |
9789089546
drshamsudeen981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College and Hospital,Cuddalore district, Annamalai nagar 608002,INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Delayed Extraction group |
Extraction of 1st premolars after initial levelling and aligning (T1 approx 6-8 months) |
| Comparator Agent |
Early extraction group |
Extraction of 1st premolars before start of orthodontic treatment (T1 - 0 months) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Class 1 bi-maxillary protrusion without any impacted teeth in maxillary and mandibular anterior region.
2.Cases requiring extraction of both maxillary and mandibular first premolar
3.Little’s index for crowding: 1- 3 mm (minimal crowding)
4.Adult patients 18-35 years of age, both male and female.
5.Patients with periodontally sound dentition.
6.Patients with good general health.
|
|
| ExclusionCriteria |
| Details |
1.Skeletal/Dental class II malocclusion
2.Skeletal/Dental class III malocclusion
3.Poor oral hygiene
4.Smoking
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of extraction space closure in early and delayed extraction of 1st premolars |
20 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess Root resorption of maxillary anterior teeth pre-treatment and post-retraction |
20 months |
| To assess Tooth angulation of maxillary incisor teeth pre-treatment and post-retraction |
20 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
25/09/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, parallel group trial investigating
in Bimaxillary protrusion patients the effect of early versus delayed extraction (premolar)
on the speed of tooth movement in orthodontic treatment by using mini
implants. The primary outcome of the study is to compare and evaluate the
rate of extraction space closure in early and delayed extraction of 1st
premolars for the period of 20 months. The secondary outcomes is to assess
root resorption of maxillary anterior teeth pre-treatment and post-retraction
and also to assess Tooth angulation of maxillary incisor teeth pre-treatment
and post-retraction for the period of 20 months. Total sample size was
calculated to be 30 including expected dropout rate of 20 %. |