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

G

Government Dental College and Research Institute, Bangalore

Status and phase

Completed
Phase 3
Phase 2

Conditions

Furcation Defects

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02609061
GDCRI/ACM/PG/PhD/2/2013-2014T

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 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% Alendronate for treating furcation defect
Treatment:
Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel form

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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