Clinical & Biochemical Effect of Atorvastatin in Nano Particles Gel in Periodontitis Treatment

NCT ID: NCT05583643

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Periodontitis is a destructive chronic inflammatory disease characterized by periodontium damage and pocket formation between the tooth and the gingival margin resulting in ultimate tooth loss. Various topical anti-inflammatory drugs were used to treat inflammation in periodontitis. Introducing atorvastatin as a novel remedy for periodontitis treatment necessitates developing a syringeable modified delivery system capable of targeting inflammation within the periodontal pockets.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phase 1 therapy

Group Type OTHER

Scaling and debridement only

Intervention Type OTHER

Scaling and debridement only

Phase 1 therapy with atorvastatin loaded into cubosomal in-situ gel

Group Type ACTIVE_COMPARATOR

Atorvastatin Calcium

Intervention Type DRUG

Atorvastatin loaded into nano particles in-situ gel adjunctive to scaling and debridement

Phase 1 therapy with atorvastatin loaded into in-situ gel

Group Type ACTIVE_COMPARATOR

Atorvastatin Calcium

Intervention Type DRUG

Atorvastatin loaded into in-situ gel adjunctive to scaling and debridement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atorvastatin Calcium

Atorvastatin loaded into nano particles in-situ gel adjunctive to scaling and debridement

Intervention Type DRUG

Atorvastatin Calcium

Atorvastatin loaded into in-situ gel adjunctive to scaling and debridement

Intervention Type DRUG

Scaling and debridement only

Scaling and debridement only

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Systemically healthy patients
* Patients with moderate periodontitis

Exclusion Criteria

* Pregnant women
* Lactating women
* Patients with chronic diseases
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Misr University for Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Heba Amin Elgendy

Teaching assistant - Pharmaceutics Department - Faculty of Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Misr University for Science and Technology (MUST)

Giza, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FWA00025577

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Simvastatin and Metformin in Chronic Periodontitis
NCT02372656 COMPLETED PHASE2/PHASE3