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OpenTrials
Completed

NCT Number: NCT05583643

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Misr University for Science and Technology (MUST)

Giza, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systemically healthy patients
  • Patients with moderate periodontitis

Exclusion criteria

  • Pregnant women
  • Lactating women
  • Patients with chronic diseases

Treatment and study plan

Atorvastatin calcium

Drug

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

Scaling and debridement only

Other

Scaling and debridement only

Primary outcomes

  1. Probing depth

    Time frame: 6 weeks

  2. Bleeding index

    Time frame: 6 weeks

  3. Plaque index

    Time frame: 6 weeks

Secondary outcomes

  1. Assessment of transforming growth factor in gingival crevicular fluid

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Misr University for Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2022
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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