| CTRI Number |
CTRI/2020/03/023781 [Registered on: 05/03/2020] Trial Registered Prospectively |
| Last Modified On: |
25/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison study of bone graft with or without injectable platelet rich fibrin in gum disease. |
|
Scientific Title of Study
|
Comparative evaluation of bone graft with or without injectable platelet rich fibrin in the treatment of mandibular grade II furcation defect: A Clinico-radiological study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Uma P Nair |
| Designation |
Post graduate |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
ROOM NO. 9, DEPARTMENT OF PERIODONTOLOGY, JSS DENTAL COLLEGE AND HOSPITAL,JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH, BANNIMANTAP, MYSORE
Mysore
KARNATAKA
570015
India |
| Phone |
8075530631 |
| Fax |
|
| Email |
umapn17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra |
| Designation |
Principal |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
JSS DENTAL COLLEGE AND HOSPITAL,JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH, BANNIMANTAP, MYSORE
Mysore
KARNATAKA
570015
India |
| Phone |
|
| Fax |
|
| Email |
drsravindra@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Uma P Nair |
| Designation |
Post graduate |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
ROOM NO. 9, DEPARTMENT OF PERIODONTOLOGY, JSS DENTAL COLLEGE AND HOSPITAL,JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH, BANNIMANTAP, MYSORE
Mysore
KARNATAKA
570015
India |
| Phone |
8075530631 |
| Fax |
|
| Email |
umapn17@gmail.com |
|
|
Source of Monetary or Material Support
|
| UMA P NAIR,ROOM NO. 9 DEPARTMENT OF PERIODONTOLOGY,JSS DENTAL COLLEGE AND HOSPITAL, BANNIMANTAP, MYSORE - 15 |
|
|
Primary Sponsor
|
| Name |
UMA P NAIR |
| Address |
DEPARMENT OF PERIODONTOLOGY, JSS DENTAL COLLEGE AND HOSPITAL, BANNIMANTAP |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| UMA P NAIR |
JSS DENTAL COLLEGE AND HOSPITAL |
ROOM NO. 9 DEPARTMENT OF PERIODONTOLOGY,JSS DENTAL COLLEGE AND HOSPITAL, BANNIMANTAP
Mysore
KARNATAKA |
8075530631
umapn17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
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 |
BONE GRAFT |
HYDROXYAPATITE BONE GRAFT |
| Intervention |
STICKY BONE |
i-PRF WITH BONE GRAFT |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Systemically healthy patients within the age group of 30-55 years both male and female
2)Clinical and radiographic evidence of mandibular buccal furcation defect ≥ 3mm
3)Vital tooth
4)Vertical probing depth ≥5mm, Horizontal probing depth ≥ 3mm
|
|
| ExclusionCriteria |
| Details |
1.Systemic illness such as diabetes, cardiovascular diseases, insufficient platelet count (<200,000/ mm3) or immunocompromised patients.
2.Patients using tobacco in any form
3.Pregnant or lactating mother
4.Known allergy to any of the material
5.Patients on any medication
6.Patients on antibiotic therapy within last 3 months
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The bone regenerative effects of i-PRF with bone graft in mandibular grade II furcation defects |
Baseline, 3 months, 6 months and 9 months post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvements in clinical and radiographical parameters |
At baseline,3,6 & 9 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
09/03/2020 |
| Date of Study Completion (India) |
11/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study was an interventional study done to compare the efficacy of i-PRF with bone graft and bone graft alone in the treatment of mandibular grade II furcation defect. A total of 12 patients were randomized using the lottery method into test and control groups. Test group (A): i-PRF with bone graft following open flap debridement Control group (B): only bone graft following open flap debridement The bone graft used were commercially available hydroxyapatite. This was a 9 months study. |