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

Primary Purpose

Periodontitis

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Atorvastatin Calcium

Scaling and debridement only

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Non-surgical treatment, Atorvastatin, Phase 1 therapy

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Systemically healthy patients
Patients with moderate periodontitis

Exclusion Criteria:

Pregnant women
Lactating women
Patients with chronic diseases

Sites / Locations

Misr University for Science and Technology (MUST)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Arm Label

Phase 1 therapy

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

Phase 1 therapy with atorvastatin loaded into in-situ gel

Arm Description

Outcomes

Primary Outcome Measures

Probing depth

Bleeding index

Plaque index

Secondary Outcome Measures

Assessment of transforming growth factor in gingival crevicular fluid

Full Information

NCT ID

NCT05583643

First Posted

October 13, 2022

Last Updated

October 17, 2022

Sponsor

Misr University for Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT05583643

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

December 7, 2021 (Actual)

Primary Completion Date

April 15, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Misr University for Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

Keywords

Periodontitis, Non-surgical treatment, Atorvastatin, Phase 1 therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1 therapy

Arm Type

Other

Arm Title

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

Arm Type

Active Comparator

Arm Title

Phase 1 therapy with atorvastatin loaded into in-situ gel

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Atorvastatin Calcium

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Atorvastatin Calcium

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Scaling and debridement only

Intervention Description

Scaling and debridement only

Primary Outcome Measure Information:

Title

Probing depth

Time Frame

6 weeks

Title

Bleeding index

Time Frame

6 weeks

Title

Plaque index

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Assessment of transforming growth factor in gingival crevicular fluid

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Systemically healthy patients Patients with moderate periodontitis Exclusion Criteria: Pregnant women Lactating women Patients with chronic diseases

Facility Information:

Facility Name

Misr University for Science and Technology (MUST)

City

Giza

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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