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Simvastatin Gel With Perforated Resorbable Membranes in Treatment of Intrabony Defects in Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Simvastatin
EDTA
Occlusive membrane
Modified perforated membrane
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Guided tissue membranes, EDTA, Simvastatin

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

    1. Probing depth > 5 mm.
    2. Clinical attachment loss >4 mm.
    3. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Simvastatin/Occlusive membrane

    Simvastatin/perforated membrane

    EDTA/Simvastatin/Occlusive membrane

    EDTA/Simvastatin/perforated membrane

    Arm Description

    open flap procedure, 1.2%simvastatin gel applied and covering the defect with resorbable collagen occlusive membrane .

    open flap procedure, 1.2% simvastatin gel and covering the defect with resorbable collagen modified perforated membrane.

    open flap procedure, 24% EDTA root surface etching,1.2% simvastatin gel and then coverage of the defect with occlusive membrane.

    open flap procedure, 24% EDTA root surface etching, 1.2% simvastatin gel and then coverage of the defect with modified perforated membrane.

    Outcomes

    Primary Outcome Measures

    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
    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
    Plaque index
    Plaque index was measured from baseline to 6 months and 9 months
    Gingival index
    Gingival index was measured from baseline to 6 months and 9 months
    Linear measurements
    Linear measurements were measured using Digora software from baseline to 6 months and 9 months
    Radiodensitometric measurements
    Bone density was measured using Digora software from baseline to 6 months and 9 months

    Secondary Outcome Measures

    Simvastatin gingival crevicular fluid levels
    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

    Full Information

    First Posted
    January 17, 2018
    Last Updated
    February 5, 2018
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03419429
    Brief Title
    Simvastatin Gel With Perforated Resorbable Membranes in Treatment of Intrabony Defects in Chronic Periodontitis
    Official Title
    The Use of Simvastatin Gel With Perforated Resorbable Membranes in the Treatment of Intrabony Defects in Chronic Periodontitis Patients (Clinical and Biochemical Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    Guided tissue membranes, EDTA, Simvastatin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Simvastatin/Occlusive membrane
    Arm Type
    Experimental
    Arm Description
    open flap procedure, 1.2%simvastatin gel applied and covering the defect with resorbable collagen occlusive membrane .
    Arm Title
    Simvastatin/perforated membrane
    Arm Type
    Experimental
    Arm Description
    open flap procedure, 1.2% simvastatin gel and covering the defect with resorbable collagen modified perforated membrane.
    Arm Title
    EDTA/Simvastatin/Occlusive membrane
    Arm Type
    Experimental
    Arm Description
    open flap procedure, 24% EDTA root surface etching,1.2% simvastatin gel and then coverage of the defect with occlusive membrane.
    Arm Title
    EDTA/Simvastatin/perforated membrane
    Arm Type
    Experimental
    Arm Description
    open flap procedure, 24% EDTA root surface etching, 1.2% simvastatin gel and then coverage of the defect with modified perforated membrane.
    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    EDTA
    Other Intervention Name(s)
    Ethylenediaminetetraacitic acid
    Intervention Description
    EDTA is a demineralizing agent used for root surface conditioning.
    Intervention Type
    Device
    Intervention Name(s)
    Occlusive membrane
    Other Intervention Name(s)
    Resorb resodont forte
    Intervention Description
    Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.
    Intervention Type
    Device
    Intervention Name(s)
    Modified perforated membrane
    Other Intervention Name(s)
    Resorb resodont forte
    Intervention Description
    Modified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated. It is used in guided tissue regeneration
    Primary Outcome Measure Information:
    Title
    Probing pocket depth
    Description
    Probing pocket depth was measured from the free gingival margin to the base of the pocket from baseline to 6 months and 9 months
    Time Frame
    Baseline to 9 months
    Title
    Clinical attachment level
    Description
    Clinical attachment level was measured from the cementoenamel junction to the base of the pocket from baseline to 6 months and 9 months
    Time Frame
    Baseline to 9 months
    Title
    Plaque index
    Description
    Plaque index was measured from baseline to 6 months and 9 months
    Time Frame
    Baseline to 9 months
    Title
    Gingival index
    Description
    Gingival index was measured from baseline to 6 months and 9 months
    Time Frame
    Baseline to 9 months
    Title
    Linear measurements
    Description
    Linear measurements were measured using Digora software from baseline to 6 months and 9 months
    Time Frame
    Baseline to 9 months
    Title
    Radiodensitometric measurements
    Description
    Bone density was measured using Digora software from baseline to 6 months and 9 months
    Time Frame
    Baseline to 9 months
    Secondary Outcome Measure Information:
    Title
    Simvastatin gingival crevicular fluid levels
    Description
    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
    Time Frame
    Day 1, 7, 14, 21 and 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Y Gamal, Professor
    Organizational Affiliation
    Faculty of dentistry- Ain Shams University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Simvastatin Gel With Perforated Resorbable Membranes in Treatment of Intrabony Defects in Chronic Periodontitis

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