Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03419429
Recruitment Status : Completed
First Posted : February 2, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Dalia Rasheed Issa, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Simvastatin Other: EDTA Device: Occlusive membrane Device: Modified perforated membrane Phase 4

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Experimental: Simvastatin/Occlusive membrane
open flap procedure, 1.2%simvastatin gel applied and covering the defect with resorbable collagen occlusive membrane .
Drug: Simvastatin
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.

Device: Occlusive membrane
Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.
Other Name: Resorb resodont forte

Experimental: Simvastatin/perforated membrane
open flap procedure, 1.2% simvastatin gel and covering the defect with resorbable collagen modified perforated membrane.
Drug: Simvastatin
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.

Device: Modified perforated membrane
Modified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated. It is used in guided tissue regeneration
Other Name: Resorb resodont forte

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.
Drug: Simvastatin
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.

Other: EDTA
EDTA is a demineralizing agent used for root surface conditioning.
Other Name: Ethylenediaminetetraacitic acid

Device: Occlusive membrane
Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.
Other Name: Resorb resodont forte

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.
Drug: Simvastatin
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.

Other: EDTA
EDTA is a demineralizing agent used for root surface conditioning.
Other Name: Ethylenediaminetetraacitic acid

Device: Modified perforated membrane
Modified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated. It is used in guided tissue regeneration
Other Name: Resorb resodont forte




Primary Outcome Measures :
  1. 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

  2. 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

  3. Plaque index [ Time Frame: Baseline to 9 months ]
    Plaque index was measured from baseline to 6 months and 9 months

  4. Gingival index [ Time Frame: Baseline to 9 months ]
    Gingival index was measured from baseline to 6 months and 9 months

  5. Linear measurements [ Time Frame: Baseline to 9 months ]
    Linear measurements were measured using Digora software from baseline to 6 months and 9 months

  6. Radiodensitometric measurements [ Time Frame: Baseline to 9 months ]
    Bone density was measured using Digora software from baseline to 6 months and 9 months


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419429


Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Study Director: Ahmed Y Gamal, Professor Faculty of dentistry- Ain Shams University

Layout table for additonal information
Responsible Party: Dalia Rasheed Issa, Associate lecturer of oral medicine and periodontology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03419429     History of Changes
Other Study ID Numbers: FDASU-RECD 12165332
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Layout table for additional information
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

Keywords provided by Dalia Rasheed Issa, Ain Shams University:
Guided tissue membranes
EDTA
Simvastatin

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Edetic Acid
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents