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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516111
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014M
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 3, 2015
• Last updated: August 4, 2015
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• Open flap debridement (OFD)
Oral prophylaxis followed by Open flap debridement (OFD)

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

Drug:
• OFD with ALN
Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect
• OFD with ATV
Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	defect depth reduction (DDR)		Change from baseline to 9 months	No
Secondary	change in clinical attachment level (CAL)		Change from baseline to 9 months	No
Secondary	change in probing pocket depths (PPD)		Change from baseline to 9 months	No
Secondary	change in plaque index (PI)		Change from baseline to 9 months	No