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

ConditionPeridontitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age25-60
SponsorMansoura University

About this trial

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-α).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators