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Completed

NCT Number: NCT02609061

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

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.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Flap Debridement (OFD)

Procedure

Open flap debridement (OFD) alone

OFD with Platelet rich fibrin (PRF)

Procedure

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

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

Procedure

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

Primary outcomes

  1. Radiographic bone fill

    Time frame: baseline to 9 months

    assessed in percentage

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2015
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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