Role of Simvastatin Microsponges in Treatment of Periodontitis

Performance of Simvastatin Microsponges as a Local Treatment for Chronic Periodontitis - Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: open flap subgingival debridement; Procedure: Subgingival injection of chitosan 2% gel; Procedure: Subgingival injection of chitosan 2% gel; Procedure: Subgingival injection of chitosan 2% gel

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Assuit, Egypt, 71111111
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Plain chitosan gel group; 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 .	Procedure: 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 was then performed and concealment from the assessors.; Procedure: Subgingival injection of chitosan 2% gel; Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly; Procedure: Subgingival injection of chitosan 2% gel; Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly; Procedure: Subgingival injection of chitosan 2% gel; Group (III); injected subgingivally with placebo chitosan 2% gel weekly
Active Comparator: Chitosan gels containing free Simvastatin; Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. .	Procedure: 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 was then performed and concealment from the assessors.; Procedure: Subgingival injection of chitosan 2% gel; Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly; Procedure: Subgingival injection of chitosan 2% gel; Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly; Procedure: Subgingival injection of chitosan 2% gel; Group (III); injected subgingivally with placebo chitosan 2% gel weekly
Experimental: Chitosan gels containing Simvastatin microsponges; This group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing .	Procedure: 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 was then performed and concealment from the assessors.; Procedure: Subgingival injection of chitosan 2% gel; Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly; Procedure: Subgingival injection of chitosan 2% gel; Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly; Procedure: Subgingival injection of chitosan 2% gel; Group (III); injected subgingivally with placebo chitosan 2% gel weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket depth	Will be measured in millimetre	Before the beginning of study
Pocket depth	Will be measured in millimetre	By the end of study after 6 months of 6 months
Clinical attachment loss	Will be measured in millimetre	Before beginning of the study
Clinical attachment loss	Will be measured in millimetre	By the end of study after 6 months of 6 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): August 10, 2020
• Study Completion (Actual): October 10, 2020

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID Numbers: Simvastatin in periodontitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No