| CTRI Number |
CTRI/2026/02/103797 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
After extraction socket preservation using dentin autograft and APRF membrane compared with demineralized freeze dried bone allograft and APRF membrane a clinical and radiographical study |
|
Scientific Title of Study
|
Post extraction socket preservation A clinico radiographic comparative study of dentin autograft and APRF membrane versus demineralized freeze dried bone allograft and APRF membrane. |
| 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 Chhayankiniben Solanki |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital sankalchand patel university |
| Address |
Room number 6 Department of Periodontology Narsinhbhai Patel Dental College and Hospital s p sahakar vidyadham ambaji gandhinagar link road near kamana char rasta Visnagar Mahesana
Mahesana GUJARAT 382440 India |
| Phone |
9408216248 |
| Fax |
|
| Email |
chaayankinisolanki22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shilpa Duseja |
| Designation |
Professor |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital Visnagar |
| Address |
Room no 6 Department of Periodontology Narsinhbhai Patel Dental College and Hospital Sankalchand Patel University Visnagar
Mahesana GUJARAT 382440 India |
| Phone |
9978909445 |
| Fax |
|
| Email |
budhirajashilpa@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Hiral Parikh |
| Designation |
Professor and HOD |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital Visnagar |
| Address |
Room no 6 Department of Periodontology Narsinhbhai Patel Dental College and Hospital Sankalchand Patel University Visnagar
Mahesana GUJARAT 382440 India |
| Phone |
9825973584 |
| Fax |
|
| Email |
drhiral10@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Room No 6
Department of Periodontology
Narsinhbhai Patel Dental College and Hospital
Sankalchand Patel University S P Sahakar Vidyadham
Ambaji Gandhinagar Link Road
Near Kamana Char Rasta
Visnagar
Mahesana
Gujarat 384315
India |
|
|
Primary Sponsor
|
| Name |
Dr Chhayankiniben Solanki |
| Address |
1 B Suncity Bunglows Visnagar link road Near railway crossing Mahesana 384001
Gujarat
India |
| 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 Chhayankiniben Solanki |
Narsinhbhai Patel Dental College and Hospital Sankalchand Patel University Visnagar |
Room number 6
Department of Periodontology Narsinhbhai Patel Dental College and Hospital
Visnagar
Mahesana 384315
Gujarat
India Mahesana GUJARAT |
9408216248
chaayankinisolanki22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Narsinhbhai Patel Dental College Sankalchand Patel University Visnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age between 18-50 years
Systemically healthy patient Individuals having class 2 or class 3 single rooted extraction socket classification by Hamoun Sabri et al 2022 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Post extraction socket preservation using autogenous dentin graft covered with APRF membrane |
Following atraumatic tooth extraction socket preservation using processed autogenous dentin graft covered with Advanced Platelet Rich Fibrin membrane Closure with sutures follow-ups at 7 days 3 and 6 months
Clinical radiographical parameters will be measured at baseline 3 months and 6
months |
| Comparator Agent |
Post extraction socket preservation using demineralized freeze dried bone allograft covered with APRF membrane |
Following atraumatic tooth extraction socket preservation using processed demineralized freeze dried bone allograft covered with Advanced Platelet Rich Fibrin membrane
Closure with sutures follow-ups at 7 days 3 and 6 months Clinical radiographical parameters will be measured at baseline 3 months and 6 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patient
Individuals having class 2 or class 3 single rooted extraction socket classification by
Hamoun Sabri et al 2022 |
|
| ExclusionCriteria |
| Details |
Patient with systemic diseases and immunological disorders
Smokers and tobacco consumption in any form
Patients with poor oral hygiene
Pregnant and lactating women
Patients undergoing orthodontic therapy
History of bisphosphonate use or any other drugs interfering with bone
metabolism
Periapical pathologies associated with the tooth to be extracted
Patients not willing for treatment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical healing of extraction socket assessed using VAS pain score and Wound Healing Index |
baseline and 7 days following socket preservation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic bone fill of extraction socket assessed using RVG |
baseline, 3 months, and 6 months following socket preservation |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
26/02/2026 |
| 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="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| 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
|
total of 20 systemically healthy patients requiring tooth extraction will be selected based on inclusion and exclusion criteria. Following atraumatic extraction, participants will be randomly allocated using coin toss into two groups. Group I: Socket preservation using autogenous dentin graft covered with Advanced Platelet-Rich Fibrin (A-PRF) membrane. Group II: Socket preservation using demineralized freeze-dried bone allograft (DFDBA) covered with Advanced Platelet-Rich Fibrin (A-PRF) membrane. Clinical parameters including pain assessment using Visual Analogue Scale (VAS) and wound healing index (Landry, Turnbull and Howley) will be evaluated at baseline and 7 days. Radiographic assessment of bone fill will be carried out using RVG (Image J software) at baseline, 3 months, and 6 months. The outcomes of both groups will be compared to evaluate the efficacy of dentin autograft with A-PRF membrane versus DFDBA with A-PRF membrane in post-extraction socket preservation. |