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Completed

NCT Number: NCT02283554

Platelet Rich Fibrin With 1% Metformin Gel for Treatment of Intrabony Defects

ABSTRACT:

Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Metformin (MF), a member of biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit a favourable effect on alveolar bone . Current study was designed to evaluate the combined efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis (CP) subjects.

Methods: One hundred and twenty subjects with single defects were categorized into four treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction was evaluated using computer-aided software at baseline and 9 months.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Presence of 3- wall intrabony defects ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA] ) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing [SRP] ) in asymptomatic molar teeth.

Exclusion criteria

  • Aggressive Periodontitis subjects
  • Subjects with 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]16 > 1.5) after re-evaluation of Phase I therapy were also excluded from the study.
  • In addition, teeth with furcation defects, non vital teeth, carious teeth warranting restorations and mobility of at least grade II were also excluded.

Treatment and study plan

Open Flap Debridement (OFD)

Procedure

Platelet rich fibrin (PRF)

Other

metformin

Drug

Primary outcomes

  1. radiographic defect depth reduction from baseline to 9 months.

    Time frame: radiographic defect depth reduction from baseline to 9 months.

    The primary outcome of the study was radiographic defect depth reduction from baseline to 9 months

Secondary outcomes

  1. Change in PD

    Time frame: Assessment of PD at 3,6 and 9 months

    PD at 3,6 and 9 months was evaluated by using a UNC-15 probe from the gingival margin to the base of pockrt

  2. Change in RAL

    Time frame: Assessment of RAL at 3,6 and 9 months

    RAL is measured by measuring the distance between apical level of customized acrylic stent to pocket base

  3. Change in GML

    Time frame: Assessment of GML at 3,6 and 9 months

    Assessment of GML is done from apical level of customized acrylic stent, using a UNC 15 periodontal probe

  4. Change in mSBI

    Time frame: Assessment of mSBI at 3,6 and 9 months

    mSBI is assessed by noting the amount of bleeding after probing, at 3,6 and 9 months

  5. Cgange in PI

    Time frame: Assessment of PI at 3,6 and 9 months

    PI is assessed by noting the amount of plaque and the site of plaque present on the tooth surface at 3,6 and 9 months

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

Platelet Rich Fibrin With 1% Metformin for the Treatment of Intrabony Defects in Chronic Periodontitis : A Randomized Controlled Clinical Trial

Important dates

Study start
2013
Primary completion
2014
First posted
Nov 5, 2014
Registry last updated
Nov 5, 2014

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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