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
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Periodontitis

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