| CTRI Number |
CTRI/2017/02/007796 [Registered on: 07/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
07/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Platelet-Rich Fibrin in combination with bone graft and bone graft alone in treatment of periodontal bone loss. |
|
Scientific Title of Study
|
Comparative Evaluation of Platelet-Rich Fibrin in Combination with NovaBone® and NovaBone® Alone in Treatment of Periodontal Intrabony Defects by RVG and CBCT : A Clinicoradiographic Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Girish H Bodhare |
| Designation |
P.G. Student |
| Affiliation |
VSPM Dental College & Research Centre |
| Address |
Dept. of Periodontics & Implantology
VSPM Dental College & Research Centre
Digdoh Hills, Hingna Road
Nagpur 440019
Maharashtra
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7709562363 |
| Fax |
|
| Email |
ghb231989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Prof. & Head |
| Affiliation |
VSPM Dental College & Research Centre |
| Address |
Dept. of Periodontics & Implantology
VSPM Dental College & Research Centre
Digdoh Hills, Hingna Road
Nagpur 440019
Maharashtra
India.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Prof. & Head |
| Affiliation |
VSPM Dental College & Research Centre |
| Address |
Dept. of Periodontics & Implantology
VSPM Dental College & Research Centre
Digdoh Hills, Hingna Road
Nagpur 440019
Maharashtra
India.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [] |
|
|
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 BODHARE GIRISH HARIPAL |
VSPM Dental College & Research Centre Nagpur |
104 Department of Periodontics and Implantology
Digdoh Hills Hingna Road
Nagpur: 440019
Nagpur
MAHARASHTRA |
07709562363
ghb231989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College and Research Centre Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Periodontitis Patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interventional trial in the treatment of chronic periodontitis involving the placement of alloplastic bone graft in combination with autologus Platelet-Rich Fibrin |
The trial is an Interventional trial in the treatment of chronic periodontitis comparing two different treatment modalities one involving the placement of alloplastic bone graft in combination with autologus Platelet-Rich Fibrin and alloplastic bone graft alone. |
| Comparator Agent |
The trial is an Interventional trial in the treatment of chronic periodontitis comparing two different treatment modalities involving the placement of alloplastic bone graft alone. |
The trial is an Interventional trial in the treatment of chronic periodontitis comparing two different treatment modalities one involving the placement of alloplastic bone graft in combination with autologus Platelet-Rich Fibrin and alloplastic bone graft alone. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with moderate to advanced periodontitis as assessed by probing pocket depth ≥ 5 mm and clinical attachment level ≥ 5 mm
2. Patients with atleast one pair of bilateral periodontal intrabony defect in either maxillary or mandibular arch.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history of systemic diseases, allergies or drug usage.
2. Subjects who have undergone periodontal treatment in previous 6 months
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Periodontal Status i.e. reduction in Probing Pocket Depth, gain in Clinical Attachment Level, Bone Fill in intrabony defect (seen by advanced radiography i.e. RVG & CBCT) within 3 to 6 months |
baseline, 6 weeks, 3 months, 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Plaque scores and Gingival Bleeding scores representing improvement in Gingival (soft tissue) status, within 3-6 months. |
baseline, 6 weeks, 3 months, 6months |
|
|
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 4 |
|
Date of First Enrollment (India)
|
10/03/2015 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Randomized, parallel group, active controlled clinical trial comparing the efficacy of glass based alloplastic bone graft material alone and combination of glass based alloplastic bone graft material with autologus Pltelet Rich Fibrin in 20 patients with chronic periodontitis exhibiting at least a pair of intrabony defects (20 sites for each group) followed by re-evaluation at 3 and 6 months. The primary outcome measures will be improvement in patient’s periodontal status (reduced probing pocket depth, gain in clinical attachment level, and bone fill at periodontal intrabony defects. The secondary outcomes will be reduction in patient’s plaque & gingival bleeding scores. |