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

NCT07754253 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-10

No results posted yet for this study

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).

Conditions

  • Peridontitis

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2026-08-17
Completion
2026-12-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754253 on ClinicalTrials.gov