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Effectiveness of Epigallocatechin-3-Gallate (Green Tea Extract) as Adjunctive Locally Delivered Nanotherapeutic in the Treatment of Stage II Periodontitis

RecruitingPhase 1Ages 25 Years - 60 YearsAllMansoura University
NCT07754253 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

The main objective of the current study is to clinically and biochemically evaluate the effectiveness of epigallocatechin-3-gallate-loaded chitosan nanoparticulate gel as a local drug delivery system, when used in conjunction with mechanical debridement, for treating periodontal pockets in patients with stage II periodontitis. The primary endpoint will be the assessment of pocket depth reduction after 3 months of therapy, whereas the secondary endpoints include the changes in clinical attachment gain, bleeding on probing, plaque and gingival indices and gingival crevicular fluid level of tumor necrosis factor alpha (TNF-ฮฑ).

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Healthy patients diagnosed with stage II and grade B periodontitis (pocket depth โ‰ค 5mm and CAL = 3-4 mm). * Patients within the age range of 25-60 years. * Good compliance with the plaque control instructions following initial therapy. 9 * Patients willing to participate in the study and will give written informed consent. Exclusion Criteria: * Patients with active systemic disease. * Periodontal treatment during the last 6 months. * Patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study. * Pregnant and lactating females. * Smokers
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What it tests

  • Ten patients with stage II periodontitis will receive epigallocatechin-3-gallate (EGCG)-loaded chitosan nanoparticulate gel injected into the periodontal pockets
  • chitosan nanoparticulate gel (CTN gel)
  • scaling and root planing (SRP) only.
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Where

1 site
Mansoura university
Al Mansurah, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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