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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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 60
Healthy Volunteers: t
View:

⁃ Healthy patients diagnosed with stage II and grade B periodontitis (pocket depth ≤ 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.

Locations
Other Locations
Egypt
Mansoura university
RECRUITING
Al Mansurah
Contact Information
Primary
Mohamed Ghanem Aldhafeeri
Dr.m.aldhafeeri@gmail.com
0021500676990
Time Frame
Start Date: 2026-03-16
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 30
Treatments
Experimental: pigallocatechin-3-gallate (EGCG)-loaded chitosan nanoparticulate gel
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.
Placebo_comparator: treated with chitosan nanoparticulate gel (CTN gel)
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.
Related Therapeutic Areas
Sponsors
Leads: Mansoura University

This content was sourced from clinicaltrials.gov