PRF+1% MF for Class II Mandibular Furcation Defects

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Furcation Defects

Treatments: Procedure: Open flap debridement (OFD); Procedure: OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form; Procedure: OFD with Platelet rich fibrin (PRF)

Study type: Interventional

Funder types: Other

Identifiers

NCT03207698

GDCRI/ACM/PG/PhD/2/2013-2014KD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups

Group 1

Active Comparator group

Description:

Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect

Treatment:

Procedure: Open flap debridement (OFD)

Group 2

Active Comparator group

Description:

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect

Treatment:

Procedure: OFD with Platelet rich fibrin (PRF)

Group 3

Active Comparator group

Description:

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Metformin for treating furcation defect

Treatment:

Procedure: OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form