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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02609061
Enrollment
72
Registered
2015-11-20
Start date
2015-01-31
Completion date
2015-09-30
Last updated
2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Furcation Defects

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.

Interventions

Open flap debridement (OFD) alone

Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement

PROCEDUREOFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel form

Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate gel placement

Sponsors

Government Dental College and Research Institute, Bangalore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Radiographic bone fillbaseline to 9 monthsassessed in percentage

Secondary

MeasureTime frameDescription
probing depthbaseline to 9 monthsmeasured in mm
Relative vertical attachment levelbaseline to 9 monthsmeasured in mm
Relative horizontal attachment levelbaseline to 9 monthsmeasured in mm
modified sulcus bleeding indexbaseline to 9 months0-3 scale
plaque indexbaseline to 9 months0-3 scale

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026