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NCT05583643 Clinical Trial

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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05583643
Other study ID # FWA00025577
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 7, 2021
Est. completion date June 30, 2022

Study information
Verified date October 2022
Source Misr University for Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date June 30, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria: - Systemically healthy patients - Patients with moderate periodontitis Exclusion Criteria: - Pregnant women - Lactating women - Patients with chronic diseases

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin Calcium
Atorvastatin loaded into nano particles in-situ gel adjunctive to scaling and debridement
• Atorvastatin Calcium
Atorvastatin loaded into in-situ gel adjunctive to scaling and debridement
Other:
• Scaling and debridement only
Scaling and debridement only

Locations
Country Name City State
Egypt Misr University for Science and Technology (MUST) Giza

Sponsors (1)
Lead Sponsor Collaborator
Misr University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Probing depth 6 weeks
Primary Bleeding index 6 weeks
Primary Plaque index 6 weeks
Secondary Assessment of transforming growth factor in gingival crevicular fluid 6 weeks
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