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

NCT07754253 | Recruiting Phase 1 DMC

• 1 other identifier: MansouraU-Epigallocatechin-3-G
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gum

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be the assessment of pocket depth reduction after 3 months of therapy

  3 moths

Secondary Outcomes (1)

• 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).

  3 months

Study Arms (3)

pigallocatechin-3-gallate (EGCG)-loaded chitosan nanoparticulate gel

EXPERIMENTAL

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

treated with chitosan nanoparticulate gel (CTN gel)

PLACEBO COMPARATOR

Drug: chitosan nanoparticulate gel (CTN gel)

scaling and root planing (SRP) only

OTHER

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.

Other: scaling and root planing (SRP) only.

Interventions

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

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.

pigallocatechin-3-gallate (EGCG)-loaded chitosan nanoparticulate gel

chitosan nanoparticulate gel (CTN gel) DRUG

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.

treated with chitosan nanoparticulate gel (CTN gel)

scaling and root planing (SRP) only. OTHER

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.

scaling and root planing (SRP) only

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlia Governorate, 22132, Egypt

RECRUITING

MeSH Terms

Interventions

Tooth Exfoliation; Root Planing; Single Person

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Central Study Contacts

Mohamed Ghanem Aldhafeeri

CONTACT

0021500676990; Dr.m.aldhafeeri@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): August 17, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

EG (1)