drugset / Trial / NCT03419429

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

NCT03419429

Phase 4 Completed 40 enrolled Ain Shams University
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2016-01
Primary completion
2017-06
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 1.2 % Other
Background EDTA Unknown 24 %

Indications