| CTRI Number |
CTRI/2025/03/083007 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARING NOVA BONE DENTAL PUTTY AND PLATELET RICH FIBRIN FOR TREATING HORIZONTAL BONY DEFECTS |
|
Scientific Title of Study
|
THE REGENERATIVE POTENTIAL OF NOVA BONE DENTAL PUTTY AND PLATELET RICH FIBRIN(PRF) IN TREATING HORIZONTAL BONY DEFECTS - A COMPARATIVE SPLIT MOUTH STUDY |
| Trial Acronym |
IMP,OFD,PRF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
FATHIMA SUHARAL |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, DEPARTMENT OF PERIODONTOLOGY, CHAPURAM, SRIKAKULAM 532401. SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, DEPARTMENT OF PERIODONTOLOGY, CHAPURAM, SRIKAKULAM 532401. Srikakulam ANDHRA PRADESH 532401 India |
| Phone |
9392346929 |
| Fax |
|
| Email |
fathimasuharal@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR ANIL KUMAR |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
DR.N.T.R UNIVERSITY OF HEALTH AND SCIENCE |
| Address |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, CHAPURAM. SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, CHAPURAM. Srikakulam ANDHRA PRADESH 532401 India |
| Phone |
9989570600 |
| Fax |
|
| Email |
anilkanc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
FATHIMA SUHARAL |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, DEPARTMENT OF PERIODONTOLOGY, CHAPURAM, SRIKAKULAM 532401.
Srikakulam ANDHRA PRADESH 532401 India |
| Phone |
9392346929 |
| Fax |
|
| Email |
fathimasuharal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
|
|
Primary Sponsor
|
| Name |
FATHIMA SUHARAL |
| Address |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE, DEPARTMENT OF PERIODONTOLOGY, CHAPURAM, SRIKAKULAM 532401 |
| 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 FATHIMA SUHARAL |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
SREE SAI DENTAL COLLEGE AND RESEACH INSTITUTE, DEPARTMENT OF PERIODONTOLOGY, CHAPURAM SRIKAKULAM 532401 Srikakulam ANDHRA PRADESH |
9392346929
fathimasuharal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
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 |
| Comparator Agent |
INTRA MARROW PENETRATION |
patients are treated with open flap debridement with intra marrow penetration and re-evaluation after 6 months |
| Intervention |
NOVA BONE PUTTY |
patients are treated with open flap debridement with intra marrow penetration and nova bone putty and re-evaluation after 6 months |
| Intervention |
PLATELET RICH FIBRIN |
patients are treated with open flap debridement with intra marrow penetration and platelet rich fibrin and re-evaluation after 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Systemically healthy patients.
2 Age: 20 - 55 years.
3 Minimum of two teeth with Probing pocket depth 5mm OR more
4 Horizontal bone loss more than or equal to 6mm measuring from cemento-enamel junction (CEJ).
|
|
| ExclusionCriteria |
| Details |
1 Medically compromised patients.
2 Teeth with grade III mobility.
3 Pregnant and lactating women.
4 Smokers.
5 Patients on medications known to interfere with periodontal tissue health and healing.
• Previous periodontal surgery on the involved teeth.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
REDUCTION IN POCKET DEPTH
CLINICAL ATTACHMENT GAIN |
BASELINE , 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque Index
Gingival Index
|
BASELINE, 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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 4 |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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="2" 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 current randomized split-mouth study consists of 15 systematically healthy patients. Patients will be chosen according to specified inclusion and exclusion criteria. Informed consent will be acquired from each patient, and subsequently, they will be randomly assigned to one of three groups. Group I patients are treated with open flap debridement with intra marrow penetration, Group II patients are treated with open flap debridement with intra marrow penetration and nova bone putty and Group III patients are treated with open flap debridement with intra marrow penetration and platelet rich fibrin. Initially scaling and root planning will be done under local anesthesia followed by oral hygiene instructions. The patient will be recalled for periodontal surgery. 1 The following clinical and radiographic parameters will be recorded at baseline and 6 months. 2 Plaque Index by Sillness and Loe 3 Gingival Index - Harald Loe & John Sillness 4 Periodontal Probing Depth 5 Clinical attachment level 6 To evaluate bone fill using CBCT
The operated site of patient will be anaesthesia. No 15 blade was used to give crevicular incision and full thickness mucoperiosteal flap will be reflected and the debridement will be done to remove granulation tissue. Micromotor handpiece and a round carbide bur will used to make intra marrow penetration in the interdental area. The required amount of Nova Bone putty and platelet rich fibrin will be taken and placed in the defect area in Group 2 and Group 3 respectively. The patient will be recalled at 6months after surgery to evaluate clinical and radiographic parameters. |