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Completed

NCT Number: NCT03419429

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Probing depth > 5 mm.
  • Clinical attachment loss >4 mm.
  • 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.

Treatment and study plan

simvastatin

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

Other

EDTA is a demineralizing agent used for root surface conditioning.

Other names: Ethylenediaminetetraacitic acid

Occlusive membrane

Device

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

Other names: Resorb resodont forte

Modified perforated membrane

Device

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

Primary outcomes

  1. 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

  2. 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

  3. Plaque index

    Time frame: Baseline to 9 months

    Plaque index was measured from baseline to 6 months and 9 months

  4. Gingival index

    Time frame: Baseline to 9 months

    Gingival index was measured from baseline to 6 months and 9 months

  5. Linear measurements

    Time frame: Baseline to 9 months

    Linear measurements were measured using Digora software from baseline to 6 months and 9 months

  6. Radiodensitometric measurements

    Time frame: Baseline to 9 months

    Bone density was measured using Digora software from baseline to 6 months and 9 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Use of Simvastatin Gel With Perforated Resorbable Membranes in the Treatment of Intrabony Defects in Chronic Periodontitis Patients (Clinical and Biochemical Study)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2018
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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