| CTRI Number |
CTRI/2026/03/107142 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
29/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Bone Graft with and without Fisetin Gel in Treating Bone Defect: A Clinical Trial |
|
Scientific Title of Study
|
Comparative Evaluation of Demineralized Freeze-Dried Bone Allograft with and without fisetin gel in the treatment of Class II Furcation Defects: A Randomized Controlled 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 |
Dr Nazish Akhtar |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh dental college and research center |
| Address |
104 DEPARTMENT OF PERIODONTOLOGY RANJEET DESHMUKH DENTAL COLLEGE , HINGNA RD,DIGDOH HILLS ,NAGPUR , MAHARASHTRA-440019
104 DEPARTMENT OF PERIODONTOLOGY RANJEET DESHMUKH DENTAL COLLEGE , HINGNA RD,DIGDOH HILLS ,NAGPUR , MAHARASHTRA-440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8237849247 |
| Fax |
|
| Email |
nazeeshakhtar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DHAWAL MODY |
| Designation |
Reader and Guide |
| Affiliation |
Ranjeet Deshmukh dental college and research center |
| Address |
104 DEPARTMENT OF PERIODONTOLOGY RANJEET DESHMUKH DENTAL COLLEGE , HINGNA RD,DIGDOH HILLS ,NAGPUR , MAHARASHTRA-440019
104 DEPARTMENT OF PERIODONTOLOGY RANJEET DESHMUKH DENTAL COLLEGE , HINGNA RD,DIGDOH HILLS ,NAGPUR , MAHARASHTRA-440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8055775977 |
| Fax |
|
| Email |
periowell@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DHAWAL MODY |
| Designation |
Reader and Guide |
| Affiliation |
Ranjeet Deshmukh dental college and research center |
| Address |
104 DEPARTMENT OF PERIODONTOLOGY RANJEET DESHMUKH DENTAL COLLEGE , HINGNA RD,DIGDOH HILLS ,NAGPUR , MAHARASHTRA-440019
104 DEPARTMENT OF PERIODONTOLOGY RANJEET DESHMUKH DENTAL COLLEGE , HINGNA RD,DIGDOH HILLS ,NAGPUR , MAHARASHTRA-440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8055775977 |
| Fax |
|
| Email |
periowell@gmail.com |
|
|
Source of Monetary or Material Support
|
| 104,Department of Periodontics and Implantology,Ranjeet Deshmukh College and Research center Nagpur-440019 India |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
104, Dept of Periodontology and implantology,Ranjeet Deshmukh Dental College and research center Nagpur-440019 |
| 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 DHAWAL MODY |
Ranjeet deshmukh dental college and research centre |
RANJEET DESHMUKH DENTAL COLLEGE , HINGNA RD,DIGDOH HILLS ,NAGPUR , MAHARASHTRA-440019
Nagpur
MAHARASHTRA |
8055775977
periowell@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College And Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DFDBA alone |
Stage III Periodontitis patients aged 30 - 60 years exhibiting 25 Class II furcation defects to be treated with DFDBA and bone graft alone. |
| Intervention |
Fisetin Gel with DFDBA |
Stage III Periodontitis aged 30 to 60 patients exhibiting 25 Class II furcation defects to be treated with Fisetin gel with DFDBA intervention frequency one time at the site |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with Stage III periodontitis as assessed by Probing Pocket Depth more than equal to 6mm, interdental Clinical Attachment Level more than equal to 5 mm and Horizontal Probing Depth more than equal to 2mm.
2 Presence of bilateral Class II furcation defects.
|
|
| ExclusionCriteria |
| Details |
1 Patients with history of systemic diseases, allergies or drug usage
2 Patients who have undergone periodontal treatment in previous 6 months
3 Pregnant and lactating females
4 Smokers or tobacco chewers
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Toevaluate and compare the effectiveness of DFDBA with or without fisetin gel in treatment of class II furcation defect clinically and radiographicallyby CBCT |
At baseline , 3 month , 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate Clinical Attachment Level (CAL), Probing Pocket Depth (PPD) and Horizontal Probing Depth (HPD) in Class II furcation defects when treated with Fisetin gel in combination with DFDBA and DFDBA alone at baseline, 3- and 6-months post operatively.
2. To evaluate radiographic bone fill obtained in Class II furcation defects when treated with fisetin gel in combination with DFDBA and DFDBA alone at baseline and 6 months post operatively by CBCT.
3. To Compare Clinical Attachment Level (CAL), Probing Pocket Depth (PPD) and Horizontal Probing Depth (HPD) in Class II furcation defects when treated with Fisetin gel in combination with DFDBA and DFDBA alone at baseline, 3- and 6-months post operatively.
4. To compare radiographic bone, fill in Class II furcation defects when treated with Fisetin gel in combination with DFDBA and DFDBA alone at baseline and 6 months post operatively by CBCT.
|
At baseline ,3 month ,6 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/06/2026 |
| 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="6"
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 study will include patients visiting the department of Periodontics and Implantology diagnosed with Stage III Periodontitis and exhibiting Class II furcation defects. Two sites in each patient will be assigned randomly for sampling. It will be conducted in Department of Periodontics and Implantology, after receiving informed consent from the patient. All the clinical and radiographical parameters will be evaluated at baseline after which the sites in the patients will be randomly and equally divided into Test and Control groups to be treated with Fisetin gel with DFDBA and DFDBA alone respectively in Class II furcation defects in Stage III Periodontitis patients. The study will be initiated after clearance from the Institutional Ethics Committee. For each patient two sites will be randomly assigned as: Group I: (Test Group) – Stage III Periodontitis exhibiting Class II furcation defects to be treated with DFDBA with Fisetin gel. Group II: (Control Group) - Stage III Periodontitis exhibiting Class II furcation defects to be treated with DFDBA alone Pre-surgical Hygiene Therapy Initial therapy will consist of detailed oral hygiene instructions and Scaling and root planing. Prior to initiating the study, its purpose and design will be explained and written informed consent will be signed by every patient. The patients will be followed up after 21 days to assess oral hygiene status. Surgical procedure: Under local anesthesia, full thickness mucoperiosteal flaps will be reflected and granulation tissue will be debrided. The root surfaces will be scaled and planed. In Group I the Class II furcation defects will be treated with DFDBA alone while in Group II the Class II furcation defects will be treated using DFDBA with Fisetin gel. The flaps will be sutured back to their original position. Periodontal dressing will be placed at the surgical sites. Post-surgical Care: Patient will be placed on antibiotics and analgesics. Sutures will be removed after 7 days. Clinical results will be evaluated at 3 and 6 months post-operatively and radiographic evaluation will be performed at 6 months post-operatively by CBCT. |