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

NCT ID: NCT03419429

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-06-30

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).

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Simvastatin/Occlusive membrane

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

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

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

Intervention Type: DEVICE

Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.

Simvastatin/perforated membrane

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

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

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

Intervention Type: DEVICE

Modified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated. It is used in guided tissue regeneration

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.

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

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

Intervention Type: OTHER

EDTA is a demineralizing agent used for root surface conditioning.

Occlusive membrane

Intervention Type: DEVICE

Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.

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.

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

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

Intervention Type: OTHER

EDTA is a demineralizing agent used for root surface conditioning.

Modified perforated membrane

Intervention Type: DEVICE

Modified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated. It is used in guided tissue regeneration

Interventions

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.

Intervention Type: DRUG

EDTA

EDTA is a demineralizing agent used for root surface conditioning.

Intervention Type: OTHER

Occlusive membrane

Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

Ethylenediaminetetraacitic acid; Resorb resodont forte; Resorb resodont forte

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

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Dalia Rasheed Issa

Associate lecturer of oral medicine and periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Y Gamal, Professor

Role: STUDY_DIRECTOR

Faculty of dentistry- Ain Shams University

Other Identifiers

FDASU-RECD 12165332

Identifier Type: -

Identifier Source: org_study_id