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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

    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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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.
Device: Occlusive membrane
Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.
Other Names:
  • Resorb resodont forte
Other: EDTA
EDTA is a demineralizing agent used for root surface conditioning.
Other Names:
  • Ethylenediaminetetraacitic acid
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.
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 Names:
  • Resorb resodont forte
Other: EDTA
EDTA is a demineralizing agent used for root surface conditioning.
Other Names:
  • Ethylenediaminetetraacitic acid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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