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RECRUITING
NCT07754253
PHASE1

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

Sponsor: Mansoura University

View on ClinicalTrials.gov

Summary

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).

Official title: Effectiveness of Epigallocatechin-3-Gallate (Green Tea Extract) as Adjunctive Locally Delivered Nanotherapeutic in the Treatment of Stage II Periodontitis (A Randomized Controlled Clinical Trial)Man

Key Details

Gender

All

Age Range

25 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-03-16

Completion Date

2026-12-20

Last Updated

2026-08-10

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Ten patients with stage II periodontitis will receive epigallocatechin-3-gallate (EGCG)-loaded chitosan nanoparticulate gel injected into the periodontal pockets

Ten patients with stage II periodontitis will receive epigallocatechin-3-gallate (EGCG)-loaded chitosan nanoparticulate gel injected into the periodontal pockets. This will be administered immediately after thorough scaling and root planing (SRP) and every 2 weeks for 6 weeks.

DRUG

chitosan nanoparticulate gel (CTN gel)

Ten patients with stage II periodontitis will be treated with chitosan nanoparticulate gel (CTN gel) injected in the pockets after SRP. Moreover, the gel application will follow the same timeframe as group I.

OTHER

scaling and root planing (SRP) only.

Ten patients with stage II periodontitis will undergo scaling and root planing (SRP) only. They will then be re-evaluated for SRP for 6 weeks.

Locations (1)

Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt