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COMPLETED
NCT03492723
NA

Garlic Product Impact on Periodontitis (GPIP)

Sponsor: Hadassah Medical Organization

View on ClinicalTrials.gov

Summary

This is a randomized, controlled, examiner-blind, 2-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 200 generally healthy adult volunteers with mild to moderate periodontitis. Subjects will be stratified and randomly assigned equally to either the regimen group (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, 12, and 18 subjects will receive oral soft tissue exams, and will have gingival inflammation, bleeding, and periodontal measurements made as described in below. Both groups will receive supragingival 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.

Official title: Placebo-Control, Randomized, Double Blind Long Term Trial to Evaluate the Efficacy of Garlic Product on Periodontitis

Key Details

Gender

All

Age Range

30 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2018-04-17

Completion Date

2020-05-30

Last Updated

2026-10-21

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Aged Garlic Extract

NR

Locations (2)

Hadassah Medical Organization,

Jerusalem, Israel

Hadassah Medical Organization

Jerusalem, Israel