MedPath

Role of Simvastatin Microsponges in Treatment of Periodontitis

Early Phase 1
Completed
Conditions
Periodontitis
Registration Number
NCT04836078
Lead Sponsor
Assiut University
Brief Summary

the aim of our study is to enhance the dissolution and subsequently the local penetration of the drug through the sulcus in addition to controlling the drug release so that, the drug could be potentially absorbed.

Detailed Description

Patients will be divided randomly into three groups: Group (I);will be treated with subgingival debridement and subgengival injection of chitosan 2% gel containing a microsponges formulated (SV), Group (II); will be treated with subgingival debridement and subgingival injection of chitosan 2% gel containing free (SV) and Group (III); will be treated by subgingival debridement and placebo gel injected subgingivally. Pocket depth and clinical attachment loss bone gain were recorded preoperative and six months postoperative for all groups.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
Inclusion Criteria
  • patients with chronic periodontitis with minimum two sites of pocket depth > 5 mm
  • patients with normal lipid profile
  • nonsmokers
  • patients free from any systemic disorders
  • committed patients to complete the treatment with follow-ups.
Exclusion Criteria
  • patients with hyperlipidemia
  • patients taking lipid lowering drugs
  • smokers
  • pregnant
  • Lactating women women, patients with mental or psychological illness and medically compromised patients.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Pocket depthBy the end of study after 6 months of 6 months

Will be measured in millimetre

Clinical attachment lossBy the end of study after 6 months of 6 months

Will be measured in millimetre

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Assiut University

🇪🇬

Assuit, Egypt

Assiut University
🇪🇬Assuit, Egypt

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