Platelet Rich Fibrin+1% Alendronate in Treatment of Mandibular Degree II Furcation Defects

Furcation Defects Clinical Trial

Official title:

Platelet Rich Fibrin Combined With 1% Alendronate Gel in Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609061
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014T
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 15, 2015
• Last updated: November 17, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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% Alendronate (Drug) in gel form
Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate 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	baseline to 9 months	No
Secondary	probing depth	measured in mm	baseline to 9 months	No
Secondary	Relative vertical attachment level	measured in mm	baseline to 9 months	No
Secondary	Relative horizontal attachment level	measured in mm	baseline to 9 months	No
Secondary	modified sulcus bleeding index	0-3 scale	baseline to 9 months	No
Secondary	plaque index	0-3 scale	baseline to 9 months	No