NCT06287424

The Efficacy Of AGE On Periodontitis

An Exploratory Eighteen Month Clinical Study To Evaluate Efficacy Of AGE Product On Periodontitis, A Dose Response Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to assess the long-term efficacy of "AGE among on deep periodontal pockets by different doses of "AGE" for a period of 18 months.

Detailed description

This is a randomized, controlled, examiner-blind, 4-treatment parallel group study. The study will be conducted at the Hebrew University, Hadassah, Israel. A sufficient number of subjects will be screened to obtain approximately 300 generally healthy adult volunteers with moderate to deep periodontal pockets. Subjects will be stratified and randomly assigned equally to either one from the 3 regimen groups with different doses of AGE or a control group (Placebo). Subjects will be requested to use the products at home for the duration of the study according to the written and verbal usage instructions given to them during product distribution. At Baseline, Month 6, Month 12, and Month 18, subjects will receive oral soft tissue exams, and will have periodontal measurements made as described in below. All groups will receive supra-gingival dental prophylaxes every 6 month consistent with local norms and standards. Products will be re-supplied approximately every six months following Baseline. During study conduct, subjects with evidence of progressive periodontal disease (≥3 mm increases in pocket depth, attachment loss or recession) will be exited from the study and treated following local norms.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Aged Garlic Extract	Subjects will be instructed to continue using their regular home oral hygiene products until the Product Distribution Visit (Visit 2). They will also be instructed not to add or change any of their regular home oral hygiene products during that time.
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2021-04-04
• Primary completion: 2022-09-30
• Completion: 2023-01-01
• First posted: 2024-03-01
• Last updated: 2024-03-01

Locations

1 site across 1 country: Israel