Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Open flap debridement (OFD)
OFD with PRF
OFD with ALN
OFD with ATV
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Open flap debridement group
PRF group
Alendronate group
Atorvastatin group
Arm Description
SRP with Open flap debridement (OFD) alone for treating intrabony defect
SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect
SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect
SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect
Outcomes
Primary Outcome Measures
defect depth reduction (DDR)
Secondary Outcome Measures
change in clinical attachment level (CAL)
change in probing pocket depths (PPD)
change in plaque index (PI)
Full Information
NCT ID
NCT02516111
First Posted
August 3, 2015
Last Updated
August 4, 2015
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT02516111
Brief Title
Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis 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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open flap debridement group
Arm Type
Active Comparator
Arm Description
SRP with Open flap debridement (OFD) alone for treating intrabony defect
Arm Title
PRF group
Arm Type
Active Comparator
Arm Description
SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect
Arm Title
Alendronate group
Arm Type
Active Comparator
Arm Description
SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect
Arm Title
Atorvastatin group
Arm Type
Active Comparator
Arm Description
SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement (OFD)
Intervention Description
Oral prophylaxis followed by Open flap debridement (OFD)
Intervention Type
Biological
Intervention Name(s)
OFD with PRF
Intervention Description
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
Intervention Type
Drug
Intervention Name(s)
OFD with ALN
Intervention Description
Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect
Intervention Type
Drug
Intervention Name(s)
OFD with ATV
Intervention Description
Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect
Primary Outcome Measure Information:
Title
defect depth reduction (DDR)
Time Frame
Change from baseline to 9 months
Secondary Outcome Measure Information:
Title
change in clinical attachment level (CAL)
Time Frame
Change from baseline to 9 months
Title
change in probing pocket depths (PPD)
Time Frame
Change from baseline to 9 months
Title
change in plaque index (PI)
Time Frame
Change from baseline to 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment
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