| CTRI Number |
CTRI/2018/10/016189 [Registered on: 29/10/2018] Trial Registered Retrospectively |
| Last Modified On: |
03/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment Of Gum Disease Using Blood units And Tissue derivatives |
|
Scientific Title of Study
|
Evaluation Of Gingival Recession Defects With Platelet Rich Fibrin Matrix And Collagen Membrane: A
Comparative Clinical Study
|
| Trial Acronym |
GTR, PRFM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveen |
| Designation |
Reader |
| Affiliation |
The Oxford Dental College |
| Address |
Department Of Periodontics, The Oxford Dental College
Bangalore
KARNATAKA
560068
India |
| Phone |
9980045451 |
| Fax |
0 |
| Email |
jayarampraveen78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen |
| Designation |
Reader |
| Affiliation |
The Oxford Dental College |
| Address |
Department Of Periodontics, The Oxford Dental College
Bangalore
KARNATAKA
560068
India |
| Phone |
9980045451 |
| Fax |
0 |
| Email |
jayarampraveen78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen |
| Designation |
Reader |
| Affiliation |
The Oxford Dental College |
| Address |
Department Of Periodontics, The Oxford Dental College
Bangalore
KARNATAKA
560068
India |
| Phone |
9980045451 |
| Fax |
0 |
| Email |
jayarampraveen78@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.R. Angelin Rejoice,
The Oxford Dental College,
Banglore |
|
|
Primary Sponsor
|
| Name |
Angelin Rejoice |
| Address |
The Oxford Dental College, Bommanahalli, Banglore-68 |
| 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 |
| Angelin Rejoice |
The oxford dental college |
Department Of Periododntics, Room: no: 4
Bangalore
KARNATAKA |
9620977991
angelinrejoicejohn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, The Oxford Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
screeing intervention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healiguide |
GTR, Type 1 COLLAGEN MEMBRANE |
| Intervention |
Merisis PRFM Kit, one step gel preparation technology |
The kit contains a Vacutainer with anticoagulant (sodium citrate) and 1.0 ml PRFM activator.
2. The Merisisâ„¢ PRFM Vacutainer should be vertically stored at room temperature.
3. Collect 9ml of blood and carefully aspirate it into the Vacutainer.
4. Remix the blood sample immediately prior to centrifugation by gently inverting the tube 4-6 times.
5. Centrifuge the tube/blood sample (Remi R8C with swing bucket rotor) at 3000 rpm for 10 minutes.
6. After centrifugation, discard the upper 40% of the supernatant (PPP).
7. Add 1.0 ml of activator given along with the kit to the remaining part of the supernatant above the gel (PRFM).
8. Final harvest is 3X to 4X PRFM up to 3ml volume. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Systemically healthy subjects.
2 Age: 18-50 years.
3 Identical bilateral Miller’s class I and II isolated gingival recession.
4 Patients with more than 1mm of width of keratinized gingiva.
• Presence of good oral hygiene maintenance
|
|
| ExclusionCriteria |
| Details |
1 History of subjects who underwent previous periodontal surgery for past 6 month.
2 Presence of dehiscence or fenestration.
3 Malposed / rotated teeth/ root caries.
4 Smokers and chewers of tobacco.
5 Pregnant or lactating mother.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Recession depth
• Recession width at cemento-enamel junction.
• Probing depth.
• Clinical attachment level.
• Keratinized gingival width.
|
baseline, 3months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival index, Plaque index |
Baseline, 3months, 6 months |
| . Assessment of soft tissue healing |
. 1 week, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/08/2017 |
| Date of Study Completion (India) |
04/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is an randomized clinical trial, aimed to find the efficacy of platelet rich fibrin matrix and collagen membrane on miller’s class I and class II gingival recession. 20 identical bilateral recession defects will be selected and randomly allocated in to Group A ( collagen membrane) and Group B ( PRFM). The procedure will be explained to the patient and informed consent is obtained. In the presurgical phase, scaling and re-evaluation carried on follwed by coronally advanced flap and placement of membrane or PRFM according to the desired site, followed by placement of periodontal dressing. Post-operative instructions are given, along with prescription of antibiotics, analgesics and chlorhexidine mouth wash. The study duration of two years, the clinical parameters will be recorded at baseline, 3 months and 6 months.
|