Efficacy of Locally Delivred 1.2% Rosuvastatin Gel in Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring chronic periodontitis, local drug delivery, rosuvastatin, osseo-differentiation
Eligibility Criteria
Inclusion Criteria:
- Systemically sound with moderate probing depth (PD) of 5- 6 mm or clinical attachment loss (CAL) of 4 - 6 mm) or deep pockets (PD ≥ 7 mm or CAL of 6 - 9 mm) and vertical bone loss ≥ 3 mm on intraoral periapical radiographs.
- Subjects with ≥ 20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy were included in the study.
Exclusion Criteria:
- Patients on systemic statin therapy with known or suspected allergy to the RSV group, patients with any other forms of periodontitis, use of tobacoo in any form, smokers, alcoholics, immune-compromised and systemically unhealthy patients, and pregnant or lactating females were excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
group I - Rosuvastatin, 1.2 mg
group II - placebo
Arm Description
Rosuvastatin- locally placed in intrabony defect sites.
placebo-placed locally in intrabony defects.
Outcomes
Primary Outcome Measures
The primary outcome of the study was complete bone defect fill.
Using radiographic analyser bone defect fill was analysed
Secondary Outcome Measures
Probing Depth.
Using UNC-15 probe
Clinical Attachment Level
Using UNC-15 probe and acrylic stents CAL was analysed
modified Sulcus BIeeding Index
Using a WALKING METHOD OF PROBING
Full Information
NCT ID
NCT02283515
First Posted
September 27, 2014
Last Updated
November 3, 2014
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT02283515
Brief Title
Efficacy of Locally Delivred 1.2% Rosuvastatin Gel in Chronic Periodontitis
Official Title
Efficacy of Locally Delivered 1.2% Rosuvastatin Gel in Non Surgical Treatment of Chronic Periodontitis Patients: A Randomised Clinical Control Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 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
BACKGROUND: Chronic periodontitis (CP) is an inflammatory condition affecting tooth supporting tissues and alveolar bone that surround the tooth leading to formation of deepend gingival sulcus that is highly prone to pathologic changes, ultimately bone resorption and tooth loss. In the literature, several pharmacologic agents have been administration via local delivery route, directly into diseased sites affirming greater improvement in periodontal status. Therefore, present study was conducted to determine the clinical effectiveness of subgingivally delivered 1.2% Rosuvastatin gel incorporated into an methylcellulose vehicle for its controlled release into intrabony defect sites in adjunct to scaling and root planing for treatment of chronic periodontitis patients.
MATERIAL AND METHODS: Sixty five patients were categorized into two treatment groups: group I -SRP plus RSV, 1.2 mg and group II -SRP plus placebo. Clinical parameters included modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL), were recorded at baseline before SRP and at 1, 3, 4, and 6 months. Radiologic assessment of intrabony defect (IBD) fill was analysed at baseline and after 6months using computer-aided software.
Detailed Description
Rosuvastatin (RSV) is one of new synthetic, second-generation, sulfur-containing, hydrophilic statin, a highly efficient competitive inhibitors of HMG CoA Reductase having important role in reducing serum cholesterol concentrations and lowers the risk of cardiovascular disease. It has potent anti-inflammatory effects, mediated via vascular endothelium derived nitric oxide (eNO) that inhibits P selectin synthesis by endothelial cells. This protective action is evidenced by reduced levels of high-sensitivity C-Reactive Protein (hs-CRP) , a clinical marker of inflammation produced in response to proinflammatory cytokines such as interleukin-6 (IL-6), therefore it contributes to the prevention and remission of inflammatory diseases. Recently, an in-vivo study demonstrated that RSV promotes osteoblast differentiation, by regulating the expression of solute carrier (Slco1a1), which may constitute the transport system for RSV across the cell membrane in mature osteoblasts.
SRP plus RSV(1.2 mg/0.1 ml) in situ gel (group I) or SRP plus placebo gel (group II) local drug delivery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
chronic periodontitis, local drug delivery, rosuvastatin, osseo-differentiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group I - Rosuvastatin, 1.2 mg
Arm Type
Active Comparator
Arm Description
Rosuvastatin- locally placed in intrabony defect sites.
Arm Title
group II - placebo
Arm Type
Placebo Comparator
Arm Description
placebo-placed locally in intrabony defects.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Hydrophilic statin
Intervention Description
Rosuvastatin (RSV) is one of new synthetic, second-generation, sulfur-containing, hydrophilic statin, a highly efficient competitive inhibitors of HMG CoA Reductase having important role in reducing serum cholesterol concentrations and lowers the risk of cardiovascular disease.
Primary Outcome Measure Information:
Title
The primary outcome of the study was complete bone defect fill.
Description
Using radiographic analyser bone defect fill was analysed
Time Frame
24 weeks complete bone defect fill.
Secondary Outcome Measure Information:
Title
Probing Depth.
Description
Using UNC-15 probe
Time Frame
an average of 24 weeks Probing depth
Title
Clinical Attachment Level
Description
Using UNC-15 probe and acrylic stents CAL was analysed
Time Frame
24 weeks
Title
modified Sulcus BIeeding Index
Description
Using a WALKING METHOD OF PROBING
Time Frame
12 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Systemically sound with moderate probing depth (PD) of 5- 6 mm or clinical attachment loss (CAL) of 4 - 6 mm) or deep pockets (PD ≥ 7 mm or CAL of 6 - 9 mm) and vertical bone loss ≥ 3 mm on intraoral periapical radiographs.
Subjects with ≥ 20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy were included in the study.
Exclusion Criteria:
Patients on systemic statin therapy with known or suspected allergy to the RSV group, patients with any other forms of periodontitis, use of tobacoo in any form, smokers, alcoholics, immune-compromised and systemically unhealthy patients, and pregnant or lactating females were excluded.
12. IPD Sharing Statement
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Efficacy of Locally Delivred 1.2% Rosuvastatin Gel in Chronic Periodontitis
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