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

Chronic Periodontitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419429
• Other study ID #: FDASU-RECD 12165332
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2018
• Last updated: February 5, 2018
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: February 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Plaque index	Plaque index was measured from baseline to 6 months and 9 months	Baseline to 9 months
Primary	Gingival index	Gingival index was measured from baseline to 6 months and 9 months	Baseline to 9 months
Primary	Linear measurements	Linear measurements were measured using Digora software from baseline to 6 months and 9 months	Baseline to 9 months
Primary	Radiodensitometric measurements	Bone density was measured using Digora software from baseline to 6 months and 9 months	Baseline to 9 months
Secondary	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	Day 1, 7, 14, 21 and 30