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

October 17, 2022 updated by: Heba Amin Elgendy, Misr University for Science and Technology

Syringeable Atorvastatin Loaded Eugenol Enriched PEGylated Cubosomes In-situ Gel for the Intra-pocket Treatment of Periodontitis: Statistical Optimization and Clinical Assessment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Misr University for Science and Technology (MUST)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemically healthy patients
  • Patients with moderate periodontitis

Exclusion Criteria:

  • Pregnant women
  • Lactating women
  • Patients with chronic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Phase 1 therapy
Other: Scaling and debridement only
Scaling and debridement only
Active Comparator: Phase 1 therapy with atorvastatin loaded into cubosomal in-situ gel
Drug: Atorvastatin Calcium
Atorvastatin loaded into nano particles in-situ gel adjunctive to scaling and debridement
Drug: Atorvastatin Calcium
Atorvastatin loaded into in-situ gel adjunctive to scaling and debridement
Active Comparator: Phase 1 therapy with atorvastatin loaded into in-situ gel
Drug: Atorvastatin Calcium
Atorvastatin loaded into nano particles in-situ gel adjunctive to scaling and debridement
Drug: Atorvastatin Calcium
Atorvastatin loaded into in-situ gel adjunctive to scaling and debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Probing depth
Time Frame: 6 weeks
6 weeks
Bleeding index
Time Frame: 6 weeks
6 weeks
Plaque index
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of transforming growth factor in gingival crevicular fluid
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Misr University for Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2021

Primary Completion (Actual)

April 15, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWA00025577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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