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

• Sponsor: Misr University for Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT05583643
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Actual Duration (Months): 6.7
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Drug: Atorvastatin Calcium; Drug: Atorvastatin Calcium; Other: Scaling and debridement only	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: 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
• Actual Study Start Date: Dec 7, 2021
• Actual Primary Completion Date: Apr 15, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

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
Active Comparator: Phase 1 therapy with atorvastatin loaded into in-situ gel	Drug: Atorvastatin Calcium; Atorvastatin loaded into in-situ gel adjunctive to scaling and debridement

Outcome Measures

Primary Outcome Measures

1. Probing depth [6 weeks]

2. Bleeding index [6 weeks]

3. Plaque index [6 weeks]

Secondary Outcome Measures

1. Assessment of transforming growth factor in gingival crevicular fluid [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Systemically healthy patients

• Patients with moderate periodontitis

Exclusion Criteria:

• Pregnant women

• Lactating women

• Patients with chronic diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Misr University for Science and Technology (MUST)	Giza		Egypt

Sponsors and Collaborators

• Misr University for Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heba Amin Elgendy, Teaching assistant - Pharmaceutics Department - Faculty of Pharmacy, Misr University for Science and Technology
• ClinicalTrials.gov Identifier: NCT05583643
• Other Study ID Numbers: FWA00025577
• First Posted: Oct 18, 2022
• Last Update Posted: Oct 19, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Heba Amin Elgendy, Teaching assistant - Pharmaceutics Department - Faculty of Pharmacy, Misr University for Science and Technology: Periodontitis; Non-surgical treatment; Atorvastatin; Phase 1 therapy
• Additional relevant MeSH terms: Periodontitis; Calcium, Dietary; Atorvastatin; Calcium

Study Results

No Results Posted as of Oct 19, 2022