| CTRI Number |
CTRI/2025/07/090162 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Studying how using platelet rich plasma which is a substance from your own blood that helps healing during the early stages of braces treatment affects the wearing down of tooth roots using Three Dimensional dental scans
|
|
Scientific Title of Study
|
Evaluation of root resorption associated with the use of platelet rich plasma during levelling and alignment of orthodontic mechanotherapy - A CBCT 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 MYAMINI SYAMALATHA |
| Designation |
post graduate |
| Affiliation |
Sibar Institute of Dental Sciences. |
| Address |
sibar institute of dental sciences
takkellapadu, Guntur
Andhra pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09938135531 |
| Fax |
|
| Email |
yaminisyamalatha999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T ASHOK KUMAR |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences. |
| Address |
sibar institute of dental sciences
takkellapadu, Guntur
Andhra pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9686874335 |
| Fax |
|
| Email |
talapaneniashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T ASHOK KUMAR |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences. |
| Address |
sibar institute of dental sciences
takkellapadu, Guntur
Andhra pradesh
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9686874335 |
| Fax |
|
| Email |
talapaneniashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| sibar dental college and hospital, takkellapadu,Guntur,522509 |
|
|
Primary Sponsor
|
| Name |
Dr. M.YAMINI SYAMALATHA |
| Address |
sibar dental college and hospital, Takkellapadu, Guntur
Andhra pradesh,522509 |
| 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 M YAMINI SYAMALATHA |
Sibar Institute of Dental Sciences. |
Department of orthodontics and dentofacial orthopaedics, roon no 6,sibar institute of dental sciences
takkellapadu, Guntur-522509
Andhra pradesh
Guntur
ANDHRA PRADESH |
09938135531
yaminisyamalatha999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS OMMITTEE SIBAR INSTITUTE OF DENTAL SCIENCES. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PLATELET RICH PLASMA |
Root resorption in mandibular anteriors with and without administration of PRP |
| Intervention |
PLATELET RICH PLASMA |
Root resorption of mandibular anteriors with administration of PRP in duration of 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Class I malocclusion with mandibular anterior crowding.
2.fully erupted permanent dentition.
3. All first premolar extraction
4.Good gingival and periodontal health
5. No systemic disease
|
|
| ExclusionCriteria |
| Details |
1. Gingival inflammation (gingivitis).
2. Poor oral hygiene.
3. Current or past evidence of periodontal disease or systemic illness.
4. Smoking habit
5. subjects who underwent orthodontic treatment before.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| volumetric change of mandibular anteriors |
baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| volumetric change of mandibular anteriors |
Base line & 6 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
N/A |
|
Date of First Enrollment (India)
|
13/09/2025 |
| 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="10"
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
|
Samples which are satisfying inclusion and exclusion criteria and will be divided into 2 groups experimental and control group. In experimental group, PRP will injected into experimental group. the volumetric root changes will be evaluated in both experimental and control groups. |