Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Atorvastatin (ATV)
Placebo Gel
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars.
Exclusion Criteria:
- patients with systemic diseases like cardiovascular disease
- diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
- pregnant/lactating females
- tobacco users
- alcoholics
- patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
- teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
- Furthermore, patients allergic to ATV or other statins or those taking ATV/other statins systemically were excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
SRP plus placebo
SRP plus Atorvastatin
Arm Description
SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally
Outcomes
Primary Outcome Measures
amount of bone fill
Secondary Outcome Measures
change in Relative vertical clinical attachment level
change in RHCAL (relative horizontal clinical attachment level)
change in probing depth
change in site specific plaque index
change in modified sulcus bleeding index
Full Information
NCT ID
NCT02386033
First Posted
November 30, 2014
Last Updated
March 5, 2015
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT02386033
Brief Title
Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects
Official Title
Clinical Efficacy of Subgingivally Delivered Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial .
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (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
ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation defects.
Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill was done at 6 and 9 months, using a computer-aided software.
Detailed Description
Two groups were made. One was delivered with ATV after SRP, the other was delivered with placebo gel after SRP.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SRP plus placebo
Arm Type
Placebo Comparator
Arm Description
SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
Arm Title
SRP plus Atorvastatin
Arm Type
Active Comparator
Arm Description
SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally
Intervention Type
Drug
Intervention Name(s)
Atorvastatin (ATV)
Other Intervention Name(s)
ATV gel
Intervention Description
After SRP, ATV gel was delivered subgingivally into the pocket
Intervention Type
Drug
Intervention Name(s)
Placebo Gel
Intervention Description
After SRP, placebo gel was delivered subgingivally into the pocket
Primary Outcome Measure Information:
Title
amount of bone fill
Time Frame
baseline to 9 months
Secondary Outcome Measure Information:
Title
change in Relative vertical clinical attachment level
Time Frame
baseline to 9 months
Title
change in RHCAL (relative horizontal clinical attachment level)
Time Frame
baseline to 9 months
Title
change in probing depth
Time Frame
baseline to 9 months
Title
change in site specific plaque index
Time Frame
baseline to 9 months
Title
change in modified sulcus bleeding index
Time Frame
baseline to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars.
Exclusion Criteria:
patients with systemic diseases like cardiovascular disease
diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
pregnant/lactating females
tobacco users
alcoholics
patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
Furthermore, patients allergic to ATV or other statins or those taking ATV/other statins systemically were excluded.
12. IPD Sharing Statement
Learn more about this trial
Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects
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