| CTRI Number |
CTRI/2023/05/052719 [Registered on: 16/05/2023] Trial Registered Prospectively |
| Last Modified On: |
11/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of bone graft and prf on bone and soft tissue morphology when placed in extraction socket during orthodontic treatment |
|
Scientific Title of Study
|
: Three dimensional evaluation of the effect of socket preservation by bone substitutes and PRP on alveolar bone, soft tissue and root length during orthodontic canine retraction: A Randomized split mouth 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 |
Prof Ashish Agrawal |
| Designation |
Professor |
| Affiliation |
faculty of dental sciences, IMS, BHU |
| Address |
Room number 3 unit of orthodontics and dentofacial orthopedics faculty of dental sciences, trauma center, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9889901616 |
| Fax |
|
| Email |
ashishdoc2000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aishwarya Nandini |
| Designation |
Junior resident |
| Affiliation |
faculty of dental sciences, IMS,BHU |
| Address |
Room number 3 unit of orthodontics and dentofacial orthopedics faculty of dental sciences, trauma center, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9628220676 |
| Fax |
|
| Email |
draishwaryabhu98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Nandini |
| Designation |
Junior resident |
| Affiliation |
faculty of dental sciences, IMS,BHU |
| Address |
Room number 3 unit of orthodontics and dentofacial orthopedics faculty of dental sciences, trauma center, BHU, Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9628220676 |
| Fax |
|
| Email |
draishwaryabhu98@gmail.com |
|
|
Source of Monetary or Material Support
|
| faculty of dental sciences, institute of medical science, BHU |
|
|
Primary Sponsor
|
| Name |
Dr. ashish agrawal |
| Address |
Room number 3 unit of orthodontics and dentofacial orthopedics faculty of dental sciences, trauma center, BHU, Varanasi |
| 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 |
| Aishwarya Nandini |
INSTITUTE OF MEDICAL SCIENCE, BHU |
Room number 3 unit of orthodontics and dentofacial orthopedics faculty of dental sciences, trauma center BHU varanasi
Varanasi
UTTAR PRADESH |
09628220676
draishwaryabhu98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
malocclusion |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Demineralized freeze dried bone allograft and
Prf
|
bone allograft and prf is placed in extraction socket in one side |
| Comparator Agent |
prf |
only prf is placed in extraction socket of other side |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
class I bimaxillary protrusion cases with average growth pattern treated with extraction of first premolars, no previous orthodontic treatment, no dentofacial anomaly, no systemic diseases, optimal oral hygiene |
|
| ExclusionCriteria |
| Details |
presence of bony defects radiographically, restoration or endodontic treatment on maxillary canine, periodontal problem |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| bony architecture, gingival morphology, root length |
before and after canine retractions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| rate of canine retraction |
at the end of canine retraction |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
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 3 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized control trial, split mouth technique, comparing the efftct of bone allograft with prf and prf alone, on bone and soft tissue architecture, conducted at unit of orthodontics and dentofacial orthopedics, faculty of dental sciences, BHU, Varanasi, India. The primary outcomes will be the bone architecture, soft tissue morphology and root length. Secondary outcome will be the rate of canine retraction. |