| CTRI Number |
CTRI/2026/03/105099 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Two Types of Bone Grafts with Injectable PRF for Bone Regeneration in Lower Back Teeth |
|
Scientific Title of Study
|
Comparative Clinical and Radiographic assessment of periodontal regeneration by employing combination of Biphasic Calcium Sulfate (CaSO4) bone graft + Injectable platelet rich fibrin (i-PRF) to Autogenous bone graft + i-PRF in management of Mandibular Grade II Furcation defects |
| Trial Acronym |
Injectable platelet rich fibrin (i-PRF)
Calcium Sulfate (CaSO4) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishnavi Ingle |
| Designation |
PG STUDENT |
| Affiliation |
Government College of dentistry, Indore |
| Address |
ROOM NO. 10, Department of Periodontology, Government College of dentistry, Indore, Opposite M.Y. Hospital Sardar Patel Marg, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9373632648 |
| Fax |
|
| Email |
vaishu11thakur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu S Ratre |
| Designation |
Professor and Head |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
ROOM NO. 10, Department of Periodontology, Government College of dentistry, Indore
67 Sanjana Park, Indore, Madhya Pradesh 452001
Indore
MADHYA PRADESH
452001
India |
| Phone |
9406928976 |
| Fax |
|
| Email |
smadhu16feb@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhu S Ratre |
| Designation |
Professor and Head |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
ROOM NO. 10, Department of Periodontology, Government College of dentistry, Indore
67 Sanjana Park, Indore, Madhya Pradesh 452001
Indore
MADHYA PRADESH
452001
India |
| Phone |
9406928976 |
| Fax |
|
| Email |
smadhu16feb@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government College of Dentistry Indore |
| Address |
Room no.10, 2nd floor, Government College of Dentistry, Indore, Oppo. M.Y. Hospital, Sardar Patel Marg, Indore 452001 |
| Type of Sponsor |
Other [Government Dental College and Hospital] |
|
|
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 Vaishnavi Ingle |
Government College of Dentistry, Indore |
ROOM NO.10,2nd floor, Department of Periodontology, Government College of Dentistry, Indore, Opposite to M.Y. Hospital, Sardar Patel Marg, Indore
Indore
MADHYA PRADESH |
9373632648
vaishu11thakur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government College of Dentistry, Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Regenerative therapy in patients with bone loss and furcation involvement |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Autogenous bone graft + i-PRF
|
Periodontal regeneration using Autogenous bone graft + i-PRF in management of mandibular grade II furcation defects |
| Intervention |
Biphasic Calcium Sulfate bone graft (CaSO4) + i-PRF |
Periodontal regeneration using Biphasic Calcium Sulfate (CaSO4) + i-PRF in mandibular grade II furcation defects |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy male or female patients aged between 20 years to 55 years who are willing to give their consent.
2.Patient with at least one mandibular molar tooth (mandibular 1st and 2 molars) with grade II furcation defect (Glickman classification 1958)
3.Patients having vertical probing pocket depth (PPD)greater than and equals to 5mm and greater than 3mm of horizontal probing depth but not entirely through and through furcation.
4.Patients willing to follow recommended plaque control and follow-up regimen and maintainable oral hygiene.
5.Patient’s having full-mouth bleeding score (FMBS)less than 20% at surgery.
6.Patient’s having greater than equals to 20 teeth present in oral cavity.
7.Patients diagnosed with Stage III periodontitis are included.
8.Patients having no history of any medication affecting periodontal healing.
|
|
| ExclusionCriteria |
| Details |
1.History of systemic diseases like diabetes mellitus, hypertension, chronic obstructive pulmonary diseases.
2.Patients with other types of furcation involvement of Grade I, III and IV.
3.Patients with severe cervical abrasion, root caries, vertical bone loss and tooth mobility grade I,II,III.
4.Patients having history of consumption of tobacco and smoking.
5.Sites with subgingival restorations and any type of prosthesis.
6.Pregnant and Lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Comparative clinical evaluation of periodontal regeneration with the use autogenous bone graft with i-PRF and Biphasic Calcium Sulfate (CaSO4) bone graft with i-PRF (Injectable platelet rich fibrin) in management of grade II furcation defects.
2.Comparative radiographic evaluation of bone fill at furcation site.
|
Pre-operative, 3 months and post-operative 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparative radiographic evaluation of bone fill at furcation site.
|
Baseline and post-op 6 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
11/03/2026 |
| 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="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
|
Comparing bone regeneration in grade 2 furcation defect in mandibular molars using biphasic calcium sulphate bone graft +i-PRF in test group and autogenous bone graft in control group with i-PRF. Group 1(Test Group) - Biphasic Calcium Sulfate bone graft +i-PRF Group 2 (Control group) - Autogenous bone graft + i-PRF Clinical parameters to be recorded at 1. Baseline 2. 3 Months 3. 6 Months
Radiographic parameters (Bone fill) recorded at Baseline and 6 months post-op |