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

NCT ID: NCT02609061

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Furcation Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect

Group Type ACTIVE_COMPARATOR

Open flap debridement (OFD)

Intervention Type PROCEDURE

Open flap debridement (OFD) alone

Group 2

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect

Group Type ACTIVE_COMPARATOR

OFD with Platelet rich fibrin (PRF)

Intervention Type PROCEDURE

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

Group 3

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate for treating furcation defect

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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Open flap debridement (OFD)

Open flap debridement (OFD) alone

Intervention Type PROCEDURE

OFD with Platelet rich fibrin (PRF)

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role lead

Responsible Party

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Dr. A R Pradeep

Professor and Head, Dept of Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Government Dental College and Research Institute

Bangalore, Karnataka, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 27712462 (View on PubMed)

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id