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Completed

NCT Number: NCT02120872

Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis

The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.

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Key information

Conditions

Three Wall Intrabony Defects in Chronic Periodontitis

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

About this study

90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects with the diagnosis of chronic periodontitis
  • presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph [IOPA])
  • interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth

Exclusion criteria

  • Subjects, with the diagnosis of aggressive periodontitis,
  • with known systemic illness and taking medications known to affect the outcomes of periodontal therapy
  • insufficient platelet count (< 200,000/mm3),
  • pregnancy / lactation
  • use of any form of tobacco
  • unacceptable oral hygiene (if plaque index [PI] (Silness & Loe 1964) >1.5) after the reevaluation of phase I therapy
  • teeth with furcation defects
  • non-vital
  • mobility of tooth ≥ Grade II

Treatment and study plan

Platelet rich fibrin and simvastatin

Drug

Three wall intrabony defect sites treated with Open Flap Debridement. 0.1 mL prepared SMV gel (1.2 mg/0.1 mL) was mixed with PRF. The PRF - SMV mixture was delivered to the defect.

Platelet rich fibrin

Biological

Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.

Open Flap Debridement alone

Procedure

Three wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect.

Primary outcomes

  1. The primary outcome measure of the study was defect depth reduction evaluated radiographically

    Time frame: At baseline and 9 month after surgery

Secondary outcomes

  1. Probing Depth

    Time frame: At baseline and 9 month after surgery

  2. Relative Attachment Level

    Time frame: At baseline and 9 month after syrgery

  3. modified Sulcul Bleeding Index

    Time frame: At baseline and 9 month after surgery

  4. Plaque Index

    Time frame: At baseline and 9 month after surgery

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

Platelet - Rich Fibrin Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 23, 2014
Registry last updated
Apr 23, 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.