The Efficacy Of AGE On Periodontitis

Periodontitis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Periodontitis

• NCT number: NCT06287424
• Study type: Interventional
• Source: Hadassah Medical Organization
• Status: Completed
• Phase: N/A
• Start date: April 4, 2021
• Completion date: January 1, 2023