| CTRI Number |
CTRI/2024/03/063590 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Effect of Concentrated Growth Factor on how much the Tooth moves in patients with fixed braces |
|
Scientific Title of Study
|
Effect of Concentrated Growth Factor on the rate of Orthodontic Tooth Movement in patients undergoing Fixed Orthodontic Therapy - an in-vivo study |
| 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 Bhavana B |
| Designation |
Post Graduate student (MDS) Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Room no 9, Fourth
floor, Department of
Orthodontics and
Dentofacial
Orthopaedics, Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam, Chennai.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9940051657 |
| Fax |
|
| Email |
dr.bhavana.ortho@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saravana Kumar |
| Designation |
Professor and Head of the Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Room no 9, Fourth
floor, Department of
Orthodontics and
Dentofacial
Orthopaedics, Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam, Chennai.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9894085953 |
| Fax |
|
| Email |
saro_sk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavana B |
| Designation |
Post Graduate student (MDS) Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Room no 9, Fourth
floor, Department of
Orthodontics and
Dentofacial
Orthopaedics, Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam, Chennai.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9940051657 |
| Fax |
|
| Email |
dr.bhavana.ortho@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Dental College and Research Institute, Kelambakkam, Tamil Nadu
|
|
|
Primary Sponsor
|
| Name |
Chettinad Dental College and Research Institute |
| Address |
Chettinad Health City, Rajiv Gandhi Salai, Kelamabakkam, Chennai - 603103. |
| 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 |
| Dr Bhavana B |
Chettinad Dental College and Research Institute |
Room no 9, Fourth
floor, Department of
Orthodontics and
Dentofacial
Orthopaedics, Chettinad Health City, Rajiv Gandhi Salai, Kelamabakkam, Chennai -
603103
Kancheepuram
TAMIL NADU |
9940051657
dr.bhavana.ortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Concentrated Growth Factor |
After extraction of the premolars, the autologous Concentrated Growth Factor obtained from the patient is placed in the freshly extracted socket and sutured on the day of extraction (day 0). Impressions are taken on days 7, 14, 30 and 60 to check the rate of tooth movement. |
| Comparator Agent |
Not applicable |
After extraction of the premolars, the freshly extracted socket is sutured on the day of extraction (day 0). Impressions are taken on days 7, 14, 30 and 60 to check the rate of tooth movement. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are undergoing fixed orthodontic treatment
Periodontally healthy patients between the age range of 13 to 35 years, includes both male and female patients.
Patients with any type of malocclusion that is indicated for all four first premolars extraction as part of treatment plan.
Patients with no previous history of orthodontic treatment
Patients without history of systemic diseases.
Patients who have offered willingness to participate and contribute to the study |
|
| ExclusionCriteria |
| Details |
Patients with previous history of orthodontic treatment
Patients with bleeding and clotting diseases.
Patients with metabolic and bone diseases.
Patients with periodontitis.
Patients with psychiatric disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of Orthodontic Tooth Movement is faster in the sites that were administered with Concentrated Growth Factor when compared with the control sites. |
0, 7, 14, 30, 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced treatment time due to placement of Concentrated Growth Factor owing to the faster rate of orthodontic tooth movement |
0, 7, 14, 30, 60 days |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
15/03/2024 |
| 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="0"
Months="2"
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 control, split mouth study in which patients who are undergoing orthodontic treatment with fixed appliance therapy who are indicated for all four first premolars are taken for the study. Autologous Concentrated Growth Factor that is obtained from the patient is placed on the test site after extraction of the tooth and sutured. The control site is the contralateral side and is devoid of placement of the growth factor. The rate of Orthodontic Tooth Movement is compared on both the test and control sites and the difference is evaluated on days 7, 14, 30 and 60. The outcome of the study would be that the rate of Orthodontic Tooth Movement will be higher at the test sites with Concentrated Growth Factor when compared to the control sites. |