- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03419429
Simvastatin Gel With Perforated Resorbable Membranes in Treatment of Intrabony Defects in Chronic Periodontitis
February 5, 2018 updated by: Dalia Rasheed Issa, Ain Shams University
The Use of Simvastatin Gel With Perforated Resorbable Membranes in the Treatment of Intrabony Defects in Chronic Periodontitis Patients (Clinical and Biochemical Study)
Modified perforated membrane (MPM) is considered as a modality that could enable participation of periosteal cells and gingival stem cells which could improve the outcomes of guided tissue regeneration more than the use of the traditional occlusive membrane (OM).
Simvastatin (SMV) modulates bone formation by increasing the expression of bone morphogenetic protein 2 and angiogenesis.
Ethylenediaminetetraacitic acid (EDTA) found to be effective as low ph etchant for smear layer removal and exposing root surface collagen.
The investigators compared the clinical and radiographic outcome of SMV gel combined with MPM to SMV gel combined with OM with and without an associated EDTA gel root surface etching for improving bone regeneration in intrabony defects in chronic periodontitis patients.
Moreover, evaluation of SMV gingival crevicular fluid (GCF) levels availability for 30 days in cases with and without EDTA root surface etching was performed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Forty patients with 40 intrabony defects having chronic periodontitis were randomly assigned into four equal groups to receive open flap procedure, 1.2% SMV gel and covering the defect with OM (Group I), open flap procedure, 1.2% SMV gel and covering the defect with MPM (Group II), open flap procedure, 24% EDTA root surface etching,1.2%
SMV gel and then coverage of the defect by OM (Goup III), or open flap procedure, 24% EDTA root surface etching, 1.2% SMV gel and then coverage of the defect by MPM (Group IV).
Plaque index, gingival index,probing pocket depth, clinical attachment level, defect base level, crestal bone level, and radiodensitometric measurements were measured at baseline and reassessed at 6 and 9 months after therapy.
Additionally, GCF was collected from group I, II, III and IV at 1,7,14, 21, and 30 days in order to evaluate SMV availability and the effect of EDTA root surface etching on its availability using High-performance liquid chromatography(HPLC).
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients were all healthy and free from any systemic disease.
- No history of antibiotic therapy or periodontal treatment for at least six months preceding the study.
- Patients were willing and able to return for multiple follow up visits.
Periodontal defects with
- Probing depth > 5 mm.
- Clinical attachment loss >4 mm.
- Standardized radiographic evidence of interproximal intrabony defect using periapical radiograph.
- Good level of oral hygiene (plaque and gingival indices score after initial phase therapy should be less than one).
Exclusion Criteria:
- Pregnancy, lactation for female patients.
- Smokers, alcoholics and those receiving any medication that could affect healing of soft tissue and bone as steroids and cyclosporines.
- History of allergic reaction to the medications used.
- Vulnerable groups and handicapped.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Simvastatin/Occlusive membrane
open flap procedure, 1.2%simvastatin gel applied and covering the defect with resorbable collagen occlusive membrane .
|
Simvastatin is a drug used orally for treatment of hypercholesterolemia.
It assists in bone regeneration and has anti-inflammatory effect when applied locally in intrabony defects for periodontal therapy.
Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.
Other Names:
|
EXPERIMENTAL: Simvastatin/perforated membrane
open flap procedure, 1.2% simvastatin gel and covering the defect with resorbable collagen modified perforated membrane.
|
Simvastatin is a drug used orally for treatment of hypercholesterolemia.
It assists in bone regeneration and has anti-inflammatory effect when applied locally in intrabony defects for periodontal therapy.
Modified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated.
It is used in guided tissue regeneration
Other Names:
|
EXPERIMENTAL: EDTA/Simvastatin/Occlusive membrane
open flap procedure, 24% EDTA root surface etching,1.2%
simvastatin gel and then coverage of the defect with occlusive membrane.
|
Simvastatin is a drug used orally for treatment of hypercholesterolemia.
It assists in bone regeneration and has anti-inflammatory effect when applied locally in intrabony defects for periodontal therapy.
Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.
Other Names:
EDTA is a demineralizing agent used for root surface conditioning.
Other Names:
|
EXPERIMENTAL: EDTA/Simvastatin/perforated membrane
open flap procedure, 24% EDTA root surface etching, 1.2% simvastatin gel and then coverage of the defect with modified perforated membrane.
|
Simvastatin is a drug used orally for treatment of hypercholesterolemia.
It assists in bone regeneration and has anti-inflammatory effect when applied locally in intrabony defects for periodontal therapy.
Modified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated.
It is used in guided tissue regeneration
Other Names:
EDTA is a demineralizing agent used for root surface conditioning.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing pocket depth
Time Frame: Baseline to 9 months
|
Probing pocket depth was measured from the free gingival margin to the base of the pocket from baseline to 6 months and 9 months
|
Baseline to 9 months
|
Clinical attachment level
Time Frame: Baseline to 9 months
|
Clinical attachment level was measured from the cementoenamel junction to the base of the pocket from baseline to 6 months and 9 months
|
Baseline to 9 months
|
Plaque index
Time Frame: Baseline to 9 months
|
Plaque index was measured from baseline to 6 months and 9 months
|
Baseline to 9 months
|
Gingival index
Time Frame: Baseline to 9 months
|
Gingival index was measured from baseline to 6 months and 9 months
|
Baseline to 9 months
|
Linear measurements
Time Frame: Baseline to 9 months
|
Linear measurements were measured using Digora software from baseline to 6 months and 9 months
|
Baseline to 9 months
|
Radiodensitometric measurements
Time Frame: Baseline to 9 months
|
Bone density was measured using Digora software from baseline to 6 months and 9 months
|
Baseline to 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Simvastatin gingival crevicular fluid levels
Time Frame: Day 1, 7, 14, 21 and 30
|
Simvastatin gingival crevicular fluid levels availability in cases with and without EDTA root surface etching using HPLC at day 1, 7, 14, 21,and 30
|
Day 1, 7, 14, 21 and 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2016
Primary Completion (ACTUAL)
June 1, 2017
Study Completion (ACTUAL)
June 1, 2017
Study Registration Dates
First Submitted
January 17, 2018
First Submitted That Met QC Criteria
January 26, 2018
First Posted (ACTUAL)
February 5, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2018
Last Update Submitted That Met QC Criteria
February 5, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Periodontitis
- Chronic Periodontitis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
Other Study ID Numbers
- FDASU-RECD 12165332
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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