| CTRI Number |
CTRI/2017/11/010669 [Registered on: 27/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
27/05/2015 |
| 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 clinical trial to compare the efficacy of thorough cleaning with placement of PepGen P-15 a bone graft and thorough cleaning alone in treatment of periodontitis patients, clinically and radiographically. |
|
Scientific Title of Study
|
A Comparative Evaluation of the Effectiveness of Anorganic Bone Matrix/Cell Binding Peptide PepGen P-15 with Open Flap Debridement (OFD) in the Treatment of Human Infrabony Defects- A Clinical and Radiographic Study |
| 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 Pratima Mishra |
| Designation |
P.G. Student |
| Affiliation |
V.S.P.M Dental College & Research Centre |
| Address |
Dept. of Periodontics & Implantology
V.S.P.M Dental College & Research Centre
Digdoh Hills, Hingna Road
Nagpur
MAHARASHTRA
440019
India |
| Phone |
07387082084 |
| Fax |
|
| Email |
dr.pratima.mishra.31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Prof. & Head |
| Affiliation |
V.S.P.M Dental College & Research Centre |
| Address |
Dept. of Periodontics & Implantology
V.S.P.M Dental College & Research Centre
Digdoh Hills, Hingna Road
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 |
V.S.P.M Dental College & Research Centre |
| Address |
Dept. of Periodontics & Implantology
V.S.P.M Dental College & Research Centre
Digdoh Hills, Hingna Road
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 |
Private medical college |
|
|
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 Pratima Mishra |
V.S.P.M Dental College & Research Centre |
Department Of Periodontics and Implantology, 104, first floor, VSPM Dental College & Research Centre
Digdoh Hills, Hingna Road
Nagpur: 440019
Nagpur
MAHARASHTRA |
07387082084
dr.pratima.mishra.31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM’S 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 |
The trial is an Interventional trial in the treatment of chronic periodontitis comparing two different treatment modalities one involving the placement of Anorganic Bone Matrix/Cell Binding Peptide (PepGen P-15) with Open Flap Debridement. |
Dose is according to size of defect, frequency is once during intrasurgical treatment, route of administration is intrasurgical. Duration is therapy is 6 months. |
| Comparator Agent |
The trial is an Interventional trial in the treatment of chronic periodontitis comparing two different treatment modalities one involving the placement of Anorganic Bone Matrix/Cell Binding Peptide (PepGen P-15) with Open Flap Debridement. |
Dose is according to size of defect, frequency is once during intrasurgical treatment, route of administration is intrasurgical. Duration is therapy is 6 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Presence of at least 2 radiographically detectable interproximal osseous defects with a probing depth ≥5mm & clinical attachment loss ≥ 5mm following initial therapy.
2. The depth of the intraosseous component of the defect estimated as ≥3mm by clinical and radiographic means.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history of systemic diseases, allergies or drug usage.
2. Subjects who have undergone periodontal treatment in previous 6 months
3. Teeth exceeding class II mobility.
|
|
|
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 |
| Primary outcomes: Improvement in Periodontal Status i.e. reduction in Probing Pocket Depth, gain in Clinical Attachment Level, Bone Fill in Periodontal Infrabony Defect (seen radiographically) |
outcome will be assessed at 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Plaque scores and Gingival Bleeding scores representing improvement in Gingival (soft tissue) status |
At 6 months |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
19/08/2013 |
| 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="1"
Days="11" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
yet to publish |
|
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 Open Flap Debridement (OFD) with placement of PepGen P-15 and OFD alone in 20 patients with chronic periodontitis exhibiting bilateral periodontal infrabony 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 defects. The secondary outcomes will be reduction in patient’s plaque & gingival bleeding scores. |