Role of Simvastatin Microsponges in Treatment of Periodontitis

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836078
• Other study ID #: Simvastatin in periodontitis
• Status: Completed
• Phase: Early Phase 1
• Start date: February 10, 2020
• Est. completion date: October 10, 2020

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 10, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.
• Subgingival injection of chitosan 2% gel
Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly
• Subgingival injection of chitosan 2% gel
Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly
• Subgingival injection of chitosan 2% gel
Group (III); injected subgingivally with placebo chitosan 2% gel weekly

Locations

Country	Name	City	State
Egypt	Assiut University	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket depth	Will be measured in millimetre	Before the beginning of study
Primary	Pocket depth	Will be measured in millimetre	By the end of study after 6 months of 6 months
Primary	Clinical attachment loss	Will be measured in millimetre	Before beginning of the study
Primary	Clinical attachment loss	Will be measured in millimetre	By the end of study after 6 months of 6 months