Role of Simvastatin Microsponges in Treatment of Periodontitis

Assiut University

Status and phase

Completed

Early Phase 1

Conditions

Periodontitis

Treatments

Procedure: open flap subgingival debridement

Procedure: Subgingival injection of chitosan 2% gel

Study type

Interventional

Funder types

Other

Identifiers

NCT04836078

Simvastatin in periodontitis

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

30 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 3 patient groups, including a placebo group

Plain chitosan gel group

Placebo Comparator group

Description:

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 .

Treatment:

Procedure: Subgingival injection of chitosan 2% gel

Procedure: open flap subgingival debridement

Chitosan gels containing free Simvastatin

Active Comparator group

Description:

Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. .

Treatment:

Procedure: Subgingival injection of chitosan 2% gel

Procedure: open flap subgingival debridement

Chitosan gels containing Simvastatin microsponges

Experimental group