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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

This trial accepts healthy volunteers

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

Design model

Parallel

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

    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.

  • 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.

  • scaling and root planing (SRP) only.

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: pigallocatechin-3-gallate (EGCG)-loaded chitosan nanoparticulate gelExperimental treatment 1 intervention
Group B: treated with chitosan nanoparticulate gel (CTN gel)Placebo comparator 1 intervention
Group C: scaling and root planing (SRP) onlyOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
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).

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov
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