Clinical trial NCT02609061: Platelet Rich Fibrin+1% Alendronate in Treatment of Mandibular Degree II Furcation Defects
Official title: Platelet Rich Fibrin Combined With 1% Alendronate Gel in Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Furcation Defects
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiographic bone fill
timeFrame: baseline to 9 months
Secondary outcomes:
measure: probing depth
timeFrame: baseline to 9 months
measure: Relative vertical attachment level
timeFrame: baseline to 9 months
measure: Relative horizontal attachment level
timeFrame: baseline to 9 months
measure: modified sulcus bleeding index
timeFrame: baseline to 9 months
measure: plaque index
timeFrame: baseline to 9 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Government Dental College and Research Institute
state: Karnataka
Study officials:
References:
citation: Kanoriya D, Pradeep AR, Garg V, Singhal S. Mandibular Degree II Furcation Defects Treatment With Platelet-Rich Fibrin and 1% Alendronate Gel Combination: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):250-258. doi: 10.1902/jop.2016.160269. Epub 2016 Oct 7.