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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609061
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

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.

Condition or disease Intervention/treatment Phase
Furcation Defects Procedure: Open flap debridement (OFD) Procedure: OFD with Platelet rich fibrin (PRF) Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel form Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Platelet Rich Fibrin Combined With 1% Alendronate Gel in Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial
Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect
Procedure: Open flap debridement (OFD)
Open flap debridement (OFD) alone

Active Comparator: Group 2
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect
Procedure: OFD with Platelet rich fibrin (PRF)
Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement

Active Comparator: Group 3
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate for treating furcation defect
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




Primary Outcome Measures :
  1. Radiographic bone fill [ Time Frame: baseline to 9 months ]
    assessed in percentage


Secondary Outcome Measures :
  1. probing depth [ Time Frame: baseline to 9 months ]
    measured in mm

  2. Relative vertical attachment level [ Time Frame: baseline to 9 months ]
    measured in mm

  3. Relative horizontal attachment level [ Time Frame: baseline to 9 months ]
    measured in mm

  4. modified sulcus bleeding index [ Time Frame: baseline to 9 months ]
    0-3 scale

  5. plaque index [ Time Frame: baseline to 9 months ]
    0-3 scale



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609061


Locations
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India
Government Dental College and Research Institute
Bangalore, Karnataka, India, 560002
Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. A R Pradeep, Professor and Head, Dept of Periodontology, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02609061    
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014T
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Furcation Defects
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs