Platelet Rich Fibrin Combined With 1% Alendronate Gel in Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Radiographic bone fill
Study Overview
Brief Summary
The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.
Detailed Description
Background: Various regenerative materials have been introduced and tested in the treatment of furcation defects. Platelet-rich fibrin (PRF) is a reservoir of growth factors and cytokines which are the key factors for regeneration of bone and maturation of the soft tissue. Alendronate (ALN), a potent member of bisphosphonate group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.
Methods: Seventy two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1% ALN (Group 3). Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative vertical attachment level (RVAL) and relative horizontal attachment level (RHAL), intrabony defect depth (IBD) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic defect fill was evaluated at baseline and 9 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Presence of buccal Class 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
- •Systemic conditions known to affect the periodontal status;
- •Medications known to affect the outcomes of periodontal therapy;
- •Hematological disorders and insufficient platelet count (<200,000/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
- •Aggressive periodontitis
Outcomes
Primary Outcomes
Radiographic bone fill
Time Frame: baseline to 9 months
assessed in percentage
Secondary Outcomes
- Relative vertical attachment level(baseline to 9 months)
- plaque index(baseline to 9 months)
- Relative horizontal attachment level(baseline to 9 months)
- probing depth(baseline to 9 months)
- modified sulcus bleeding index(baseline to 9 months)
Investigators
Dr. A R Pradeep
Professor and Head, Dept of Periodontology
Government Dental College and Research Institute, Bangalore