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Trial record 16 of 312 for:    "Periodontitis, Chronic"

Efficacy of Locally Delivred 1.2% Rosuvastatin Gel in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02283515
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : November 5, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Rosuvastatin Phase 2 Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Locally Delivered 1.2% Rosuvastatin Gel in Non Surgical Treatment of Chronic Periodontitis Patients: A Randomised Clinical Control Trial.
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group I - Rosuvastatin, 1.2 mg
Rosuvastatin- locally placed in intrabony defect sites.
Drug: Rosuvastatin
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.
Other Name: Hydrophilic statin

Placebo Comparator: group II - placebo
placebo-placed locally in intrabony defects.



Primary Outcome Measures :
  1. The primary outcome of the study was complete bone defect fill. [ Time Frame: 24 weeks complete bone defect fill. ]
    Using radiographic analyser bone defect fill was analysed


Secondary Outcome Measures :
  1. Probing Depth. [ Time Frame: an average of 24 weeks Probing depth ]
    Using UNC-15 probe

  2. Clinical Attachment Level [ Time Frame: 24 weeks ]
    Using UNC-15 probe and acrylic stents CAL was analysed

  3. modified Sulcus BIeeding Index [ Time Frame: 12 and 24 weeks ]
    Using a WALKING METHOD OF PROBING



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Dr. A R Pradeep, Proffesor and Head, dept of periodontology, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02283515     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/10/2013-14A
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014

Keywords provided by Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore:
chronic periodontitis
local drug delivery
rosuvastatin
osseo-differentiation

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors