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

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ClinicalTrials.gov Identifier: NCT02516111
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Open flap debridement (OFD) Biological: OFD with PRF Drug: OFD with ALN Drug: OFD with ATV Phase 2 Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Open flap debridement group
SRP with Open flap debridement (OFD) alone for treating intrabony defect
Procedure: Open flap debridement (OFD)
Oral prophylaxis followed by Open flap debridement (OFD)

Active Comparator: PRF group
SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect
Biological: OFD with PRF
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect

Active Comparator: Alendronate group
SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect
Drug: OFD with ALN
Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect

Active Comparator: Atorvastatin group
SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect
Drug: OFD with ATV
Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect




Primary Outcome Measures :
  1. defect depth reduction (DDR) [ Time Frame: Change from baseline to 9 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Dr. A R Pradeep, Professor and Head, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02516111     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014M
First Posted: August 5, 2015    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Atorvastatin
Alendronate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Bone Density Conservation Agents
Physiological Effects of Drugs