Simvastatin Gel With Perforated Resorbable Membranes in Treatment of Intrabony Defects in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

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).
    

Intervention name(s): Simvastatin; EDTA; Occlusive membrane; Modified perforated membrane
Intervention type(s): Drug; Other; Device; Device
Intervention description(s): 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 is a demineralizing agent used for root surface conditioning.; Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.; Modified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated. It is used in guided tissue regeneration
Other intervention name(s): Ethylenediaminetetraacitic acid; Resorb resodont forte; Resorb resodont forte
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Guided tissue membranes; EDTA; Simvastatin