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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02609061
Other study ID # GDCRI/ACM/PG/PhD/2/2013-2014T
Secondary ID
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


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
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Completed NCT02102360 - Conventional or Minimally Invasive Surgical Technique for the Treatment of Furcation Defects Using Enamel Matrix Derivative and Anorganic Bovine Bone - a Randomized Controlled Clinical Trial. Phase 4
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Completed NCT03354182 - Surgical Treatment of Mandibular Furcations Using a Xenograft With/Without a Collagen Membrane N/A