| CTRI Number |
CTRI/2026/02/103153 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bone Healing After Tooth Removal in Patients Using Bone Graft With Membrane Compared to Platelet-Rich Fibrin |
|
Scientific Title of Study
|
Comparative evaluation of bone dimensional changes in
extraction socket followed by socket preservation with freeze dried bone allograft with
collagen membrane Versus PRF-Assisted Healing: A Split-mouth, Randomized, Controlled
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 |
Hemant Kumar Teli |
| Designation |
Pg Student |
| Affiliation |
Government Dental College And Hospital Jamnagar |
| Address |
Room no 06, Department of Periodontology and Implantology,Pathikashram Main Rd, Navagam Ghed
Jamnagar
GUJARAT
361008
India |
| Phone |
6355569355 |
| Fax |
|
| Email |
hemantdt565@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana G Patel |
| Designation |
Dean, Professor & Head Of Periodontia Department |
| Affiliation |
Government Dental College And Hospital Jamnagar |
| Address |
Room no 06, Department of Periodontology and Implantology,Pathikashram Main Rd, Navagam Ghed,
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hemant Kumar Teli |
| Designation |
Pg Student |
| Affiliation |
Government Dental College And Hospital Jamnagar |
| Address |
Room no 06, Department of Periodontology and Implantology,Pathikashram Main Rd, Navagam Ghed,
Jamnagar
GUJARAT
361008
India |
| Phone |
6355569355 |
| Fax |
|
| Email |
hemantdt565@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hemant Kumar teli |
| Address |
Room no 06, Department of Periodontology and Implantology,Pathikashram Main Rd, Navagam Ghed,
Jamnagar
GUJARAT
Pin 361008 |
| 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 Hemant Kumar teli |
Government Dental College And Hospital Jamnagar |
Room no 06, Department of Periodontology and Implantology,Pathikashram Main Rd, Navagam Ghed,
Jamnagar
GUJARAT |
6355569355
hemantdt565@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, M.P. Shah Government Medical College & Guru Gobindsingh Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Freeze-dried bone allograft with collagen membrane |
Socket preservation performed immediately after tooth extraction using freeze-dried bone allograft placed into the extraction socket and covered with a resorbable collagen membrane.
study will be done in duration of 2 years |
| Comparator Agent |
Platelet-rich fibrin (PRF) |
Platelet-rich fibrin prepared from autologous venous blood and placed into the extraction socket immediately after tooth extraction to aid natural healing.
study will be done in duration of 2 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
18 to 60 years of age
Single rooted incisor canine or premolar tooth requiring extraction due to severe decay
root pieces inability to restore root fracture periodontal disease failed endodontic
treatment
Radiographic bone height of more than or equal to 4 mm at site intended for surgery |
|
| ExclusionCriteria |
| Details |
1. Patients with acute periapical or periodontal infections.
2. Inability to maintain adequate oral hygiene. (Full mouth plaque level of more than
30Percentage).
3. Any medical condition that contraindicated surgery. (Uncontrolled systemic diseases).
4. History of malignancy, radiotherapy, or chemotherapy.
5. Pregnancy or lactation
6. Absence of one or two adjacent teeth.
7. Smokers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in alveolar bone dimensions (vertical and horizontal) |
Baseline (immediately post-extraction) and 6 months post-extraction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain assessment using Visual Analog Scale (VAS) |
Day 1, Day 3, and Day 7 post-extraction |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
This randomized split mouth clinical trial aims to compare bone dimensional changes following tooth extraction managed with socket preservation using freeze dried bone allograft with collagen membrane versus platelet rich fibrin assisted healing. Systemically healthy patients requiring bilateral tooth extraction will be included. In each patient one extraction socket will receive freeze dried bone allograft with collagen membrane and the contralateral socket will receive platelet rich fibrin. The primary objective is to evaluate changes in vertical and horizontal alveolar bone dimensions at baseline and six months post extraction. Secondary objectives include assessment of soft tissue healing and post operative pain. The hypothesis is that socket preservation using freeze dried bone allograft with collagen membrane will result in reduced alveolar bone resorption compared to platelet rich fibrin assisted healing. |