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Completed

NCT Number: NCT02516111

Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment

The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.

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Key information

About this study

Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of autologous PRF, 1% alendronate and 1.2% atorvastatin gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.

Methods: 120 CP subjects with IBD ≥3 mm deep and probing depth (PD) ≥5 mm, following scaling and root planing (SRP), were categorized into four treatment groups: 1) OFD 2) OFD with PRF 3) OFD with 1% ALN gel and 4) OFD with 1.2% ATV gel. Clinical parameters including site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and relative attachment level (RAL) as well as percentage radiographic intrabony defect depth reduction (DDR) were recorded at baseline before surgery and 9 months post-operatively.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

Exclusion criteria

  • Patients with a known systemic disease
  • Known or suspected allergy to the ALN/ bisphosphonates or ATV/statin group
  • On systemic ALN/ bisphosphonates or ATV/statin group
  • With aggressive periodontitis
  • Who used tobacco in any form
  • Alcoholics
  • Immunocompromised patients
  • And pregnant or lactating females were excluded from the study

Treatment and study plan

Open Flap Debridement (OFD)

Procedure

Oral prophylaxis followed by Open flap debridement (OFD)

OFD with PRF

Biological

Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect

OFD with ALN

Drug

Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect

OFD with ATV

Drug

Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect

Primary outcomes

  1. defect depth reduction (DDR)

    Time frame: Change from baseline to 9 months

Secondary outcomes

  1. change in clinical attachment level (CAL)

    Time frame: Change from baseline to 9 months

  2. change in probing pocket depths (PPD)

    Time frame: Change from baseline to 9 months

  3. change in plaque index (PI)

    Time frame: Change from baseline to 9 months

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

Comparative Evaluation of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Treatment of 2/3-walled Intrabony Defects in Chronic Periodontitis Subjects: a Randomized Controlled Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2015
Registry last updated
Aug 5, 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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