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CompletedNCT03207698Updated Jul 5, 2017

PRF+1% MF for Class II Mandibular Furcation Defects

A Phase 2/3 interventional study of Open flap debridement (OFD) and OFD with Platelet rich fibrin (PRF) in Furcation Defects, sponsored by Government Dental College and Research Institute, Bangalore. Completed at 1 site in India. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-05.

Sponsored by Government Dental College and Research Institute, Bangalore · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study summary

The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.

Read the detailed description

Background: For improving efficacy and outcomes of regenerative therapy for furcation defects, various materials has been investigated in addition to access therapy. Platelet-rich fibrin (PRF) having concentrated growth factors and cytokines and Metformin (MF), an efficacious member of biguanide group are known to enhance periodontal regeneration. The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.

Methods: This randomized trial was conducted on 75 patients with mandibular class II furcation defects. Defects were surgically treated with either access therapy alone (Group 1), access therapy+PRF (Group 2), and access therapy+ PRF+1% MF (Group 3). Clinical parameters like probing depth (PD), relative clinical attachment level {vertical (RVCAL) and horizontal (RHCAL)}, modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were evaluated at baseline and 9 months post-operatively. Radiological assessment of bone defect fill was done at baseline and 9 months.

02

Conditions studied

  • Furcation Defects

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03

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Buccal degree 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

Exclusion Criteria:

Aggressive periodontitis patients

  • Systemic conditions known to affect the periodontal status;
  • Medications known to affect the outcomes of periodontal therapy;
  • Hematological disorders and insufficient platelet count (\<100,000/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 were also excluded.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Active comparator
    Group 1

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

    Procedure: Open flap debridement (OFD)

  • 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)

  • Active comparator
    Group 3

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

    Procedure: OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form

Interventions

  • ProcedureOpen flap debridement (OFD)

    Open flap debridement (OFD) alone

  • ProcedureOFD with Platelet rich fibrin (PRF)

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

  • ProcedureOFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form

    Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement

05

What researchers measure

Primary outcomes

  1. Radiographic bone fill assessed in percentage

    assessed in percentage

    Time frame: baseline to 9 months

Secondary outcomes

  1. probing depth measured in mm

    measured in mm

    Time frame: baseline to 9 months

  2. Relative vertical attachment level measured in mm

    measured in mm

    Time frame: baseline to 9 months

  3. Relative horizontal attachment level measured in mm

    measured in mm

    Time frame: baseline to 9 months

  4. modified sulcus bleeding index

    0-3 scale

    Time frame: baseline to 9 months

  5. plaque index

    0-3 scale

    Time frame: baseline to 9 months

06

Study locations

1 site
  • Government Dental College and Research Institute
    Bangalore, Karnataka 560002, India
07

Registry details

Key details

Study ID
NCT03207698
Lead sponsor
Government Dental College and Research Institute, Bangalore
Responsible party
Dr. A R Pradeep (Professor and Head, Dept of Periodontology, Government Dental College and Research Institute, Bangalore) — Principal investigator
First posted
Jul 5, 2017
Start date
Sep 2015
Primary completion
May 2016
Completion
May 2016
Last update
Jul 5, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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