| CTRI Number |
CTRI/2023/10/058270 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
27/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of blood-derived products on bone healing after surgery : A randomized clinical trial |
|
Scientific Title of Study
|
The effect of concentrated growth factor (SGF) and Platelet Rich Fibrin (PRF) on post endodontic surgery healing : A randomized clinical 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 |
Supriya choudhary |
| Designation |
Junior resident |
| Affiliation |
KGMU,Lucknoww |
| Address |
Department of Conservative Dentistry and Endodontics,
1ST FLOOR, Old dental building
Faculty of Dental Sciences, KGMU
Chowk
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9731565808 |
| Fax |
|
| Email |
supriyachoudhary2596@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Bharti |
| Designation |
Professor |
| Affiliation |
FODS, KGMU |
| Address |
Department of Conservative Dentistry and Endodontics,
1ST FLOOR, Old dental building
Faculty of Dental Sciences, KGMU
Chowk
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
993572473 |
| Fax |
|
| Email |
rameshbharti@kgmcindia.edu |
|
Details of Contact Person
Public Query
|
| Name |
Supriya choudhary |
| Designation |
Junior resident |
| Affiliation |
FODS, KGMU |
| Address |
Department of Conservative Dentistry and Endodontics,
1ST FLOOR, Old dental building
Faculty of Dental Sciences, KGMU
Chowk
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9731565808 |
| Fax |
|
| Email |
supriyachoudhary2596@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative dentistry and endodontics,
1st floor, Old dental building
Faculty of Dental sciences
KGMU,
Lucknow-226003 |
|
|
Primary Sponsor
|
| Name |
Supriya Choudhary |
| Address |
Department of Conservative dentistry and endodontics,
1st floor, Old dental building
Faculty of Dental sciences
KGMU,
Lucknow-226003 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Supriya Choudhary |
King Georges Medical University |
Department of Conservative Dentistry and Endodontics, 1st floor, Old dental building
Faculty of Dental Sciences,KGMU,
Chowk
Lucknow
Lucknow
UTTAR PRADESH |
9731565808
supriyachoudhary2596@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KGMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M268||Other dentofacial anomalies, (2) ICD-10 Condition: K046||Periapical abscess with sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Concentrated Growth factor, Platelet rich fibrin |
Concentrated Growth factor, Platelet rich fibrin
total duration of intervention- 6 months
|
| Comparator Agent |
Periapical surgery with no platelet concentrates plaed in bone defect |
Periapical surgery with no platelet concentrates plaed in bone defect |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
All patients within 18–40 years of age.
Single rooted, anterior teeth.
Teeth with peri apical radiolucency indicated for surgery.
Patients who are not on any medication affecting periapical healing. (corticosteroids, chemotherapeutic agents, nonâ€steroidal anti†inflammatory drugs (NSAIDs), antibiotics, anticoagulants and drugs which reduce osteoclastic activity).
|
|
| ExclusionCriteria |
| Details |
Patients who did not give their consent for participating in the study.
Patients having insufficient motivation to report back for follow up visits.
Patients with any systemic diseases like diabetes mellitus, hypertension, hepatitis, Human immunodeficiency virus, bone disorders, autoâ€immune disorders.
Surgical retreatment cases.
Patients with malignant tumors or undergoing chemotherapy/ radiotherapy.
Pregnant females.
Patients with periodontally compromised teeth.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Surface area reduction |
0,1,3,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peak systolic velocity |
0,1,3,6 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/10/2023 |
| 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="1"
Months="0"
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
|
The present study
will be conducted in the Department of Conservative Dentistry and
Endodontics, Faculty of Dental Sciences, King G eorge’s Medical University
(KGMU), Lucknow. Background The overall success of a periapical surgery is assessed in terms of
regeneration of functional periradicular tissues. The regenerative potential of
platelets has been well documented. The use of concentrated growth factors (CGF),
a new family of autologous platelet concentrates, has been under study as a sole
material for bone regeneration after periapical surgery. Purpose To study the
efficacy of CGF and PRF in neo angiogenesis and bone healing using color
doppler and CBCT •Study design : This is a randomized clinical trial. •Investigating procedures : •The following investigations will be
done at baseline and follow up appointments 1.CBCT
2.Color doppler |