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

Misr University for Science and Technology

Status and phase: Completed; Phase 1

Conditions: Periodontitis

Treatments: Other: Scaling and debridement only; Drug: Atorvastatin Calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT05583643

FWA00025577

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Systemically healthy patients
• Patients with moderate periodontitis

Exclusion criteria

• Pregnant women
• Lactating women
• Patients with chronic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 3 patient groups

Phase 1 therapy

Other group

Treatment:

Other: Scaling and debridement only

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

Active Comparator group

Treatment:

Drug: Atorvastatin Calcium

Drug: Atorvastatin Calcium

Phase 1 therapy with atorvastatin loaded into in-situ gel

Active Comparator group

Treatment:

Drug: Atorvastatin Calcium

Drug: Atorvastatin Calcium