Role of Simvastatin Microsponges in Treatment of Periodontitis

Early Phase 1

Completed

• Conditions: Periodontitis
• Interventions: Procedure: open flap subgingival debridement; Procedure: Subgingival injection of chitosan 2% gel

• 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.

Study Timeline

• Study Start: 2020-02-10
• Primary Completion: 2020-08-10
• Study Completion: 2020-10-10
• Study First Submitted: 2021-03-25
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-05
• Last Update Submitted: 2021-04-05
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08

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

Arm && Interventions

Group	Intervention	Description
Plain chitosan gel group	open flap subgingival debridement	After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement . Randomization will be performed and concealment from the assessors. For root conditioning purpose, Group (I) ; will be injected subgingivally with chitosan 2% gel .
Chitosan gels containing free Simvastatin	Subgingival injection of chitosan 2% gel	Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. .
Plain chitosan gel group	Subgingival injection of chitosan 2% gel	After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement . Randomization will be performed and concealment from the assessors. For root conditioning purpose, Group (I) ; will be injected subgingivally with chitosan 2% gel .
Chitosan gels containing Simvastatin microsponges	open flap subgingival debridement	This group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing .
Chitosan gels containing free Simvastatin	open flap subgingival debridement	Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. .
Chitosan gels containing Simvastatin microsponges	Subgingival injection of chitosan 2% gel	This group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing .

Primary Outcome Measures

Name	Time	Method
Clinical attachment loss	By the end of study after 6 months of 6 months	Will be measured in millimetre
Pocket depth	By the end of study after 6 months of 6 months	Will be measured in millimetre

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assuit, Egypt