- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03207698
PRF+1% MF for Class II Mandibular Furcation Defects
Evaluation of Adjunctive Effect of 1% Metformin To Platelet Rich Fibrin For Mandibular Class II Furcation Defects: A Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Detailed Description
Background: For improving efficacy and outcomes of regenerative therapy for furcation defects, various materials has been investigated in addition to access therapy. Platelet-rich fibrin (PRF) having concentrated growth factors and cytokines and Metformin (MF), an efficacious member of biguanide group are known to enhance periodontal regeneration. The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.
Methods: This randomized trial was conducted on 75 patients with mandibular class II furcation defects. Defects were surgically treated with either access therapy alone (Group 1), access therapy+PRF (Group 2), and access therapy+ PRF+1% MF (Group 3). Clinical parameters like probing depth (PD), relative clinical attachment level {vertical (RVCAL) and horizontal (RHCAL)}, modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were evaluated at baseline and 9 months post-operatively. Radiological assessment of bone defect fill was done at baseline and 9 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Karnataka
-
Bangalore, Karnataka, India, 560002
- Government Dental College and Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);
- No history of antibiotic or periodontal therapy in the preceding 6 months.
Exclusion Criteria:
Aggressive periodontitis patients
- Systemic conditions known to affect the periodontal status;
- Medications known to affect the outcomes of periodontal therapy;
- Hematological disorders and insufficient platelet count (<100,000/mm3);
- Pregnancy/lactation;
- Smoking and tobacco use in any form
- Immunocompromised individuals;
- Those having unacceptable oral hygiene (plaque index [PI] >1.5).
- Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect
|
Open flap debridement (OFD) alone
|
Active Comparator: Group 2
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect
|
Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
|
Active Comparator: Group 3
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Metformin for treating furcation defect
|
Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2%
Atorvastatin gel placement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographic bone fill assessed in percentage
Time Frame: baseline to 9 months
|
assessed in percentage
|
baseline to 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
probing depth measured in mm
Time Frame: baseline to 9 months
|
measured in mm
|
baseline to 9 months
|
Relative vertical attachment level measured in mm
Time Frame: baseline to 9 months
|
measured in mm
|
baseline to 9 months
|
Relative horizontal attachment level measured in mm
Time Frame: baseline to 9 months
|
measured in mm
|
baseline to 9 months
|
modified sulcus bleeding index
Time Frame: baseline to 9 months
|
0-3 scale
|
baseline to 9 months
|
plaque index
Time Frame: baseline to 9 months
|
0-3 scale
|
baseline to 9 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GDCRI/ACM/PG/PhD/2/2013-2014KD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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