Simvastatin Gel With Perforated Resorbable Membranes in Treatment of Intrabony Defects in Chronic Periodontitis
The Use of Simvastatin Gel With Perforated Resorbable Membranes in the Treatment of Intrabony Defects in Chronic Periodontitis Patients (Clinical and Biochemical Study)
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 17, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedFebruary 6, 2018
February 1, 2018
1.4 years
January 17, 2018
February 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Probing pocket depth
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
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
Plaque index was measured from baseline to 6 months and 9 months
Baseline to 9 months
Gingival index
Gingival index was measured from baseline to 6 months and 9 months
Baseline to 9 months
Linear measurements
Linear measurements were measured using Digora software from baseline to 6 months and 9 months
Baseline to 9 months
Radiodensitometric measurements
Bone density was measured using Digora software from baseline to 6 months and 9 months
Baseline to 9 months
Secondary Outcomes (1)
Simvastatin gingival crevicular fluid levels
Day 1, 7, 14, 21 and 30
Study Arms (4)
Simvastatin/Occlusive membrane
EXPERIMENTALopen flap procedure, 1.2%simvastatin gel applied and covering the defect with resorbable collagen occlusive membrane .
Simvastatin/perforated membrane
EXPERIMENTALopen flap procedure, 1.2% simvastatin gel and covering the defect with resorbable collagen modified perforated membrane.
EDTA/Simvastatin/Occlusive membrane
EXPERIMENTALopen flap procedure, 24% EDTA root surface etching,1.2% simvastatin gel and then coverage of the defect with occlusive membrane.
EDTA/Simvastatin/perforated membrane
EXPERIMENTALopen flap procedure, 24% EDTA root surface etching, 1.2% simvastatin gel and then coverage of the defect with modified perforated membrane.
Interventions
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.
EDTA is a demineralizing agent used for root surface conditioning.
Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.
Modified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated. It is used in guided tissue regeneration
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed Y Gamal, Professor
Faculty of dentistry- Ain Shams University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate lecturer of oral medicine and periodontology
Study Record Dates
First Submitted
January 17, 2018
First Posted
February 5, 2018
Study Start
January 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
February 6, 2018
Record last verified: 2018-02