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Role of Simvastatin Microsponges in Treatment of Periodontitis

NCT04836078 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-04-08

No results posted yet for this study

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.

Conditions

  • Periodontitis

Interventions

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2020-08-10
Completion
2020-10-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04836078 on ClinicalTrials.gov