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Role of Simvastatin Microsponges in Treatment of Periodontitis

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04836078
Enrollment
24
Registered
2021-04-08
Start date
2020-02-10
Completion date
2020-10-10
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

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.

Interventions

PROCEDUREopen 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.

PROCEDURESubgingival injection of chitosan 2% gel

Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pocket depthBefore the beginning of studyWill be measured in millimetre
Clinical attachment lossBefore beginning of the studyWill be measured in millimetre

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026