PRF+1% MF for Class II Mandibular Furcation Defects

Furcation Defects Clinical Trial

Official title:

Evaluation of Adjunctive Effect of 1% Metformin To Platelet Rich Fibrin For Mandibular Class II Furcation Defects: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207698
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014KD
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 1, 2017
• Last updated: July 1, 2017
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2017
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Furcation Defects

Intervention

Procedure:
• Open flap debridement (OFD)
Open flap debridement (OFD) alone
• OFD with Platelet rich fibrin (PRF)
Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
• OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form
Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic bone fill assessed in percentage	assessed in percentage	baseline to 9 months
Secondary	probing depth measured in mm	measured in mm	baseline to 9 months
Secondary	Relative vertical attachment level measured in mm	measured in mm	baseline to 9 months
Secondary	Relative horizontal attachment level measured in mm	measured in mm	baseline to 9 months
Secondary	modified sulcus bleeding index	0-3 scale	baseline to 9 months
Secondary	plaque index	0-3 scale	baseline to 9 months