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Garlic Product Impact on Periodontitis (GPIP)
Sponsor: Hadassah Medical Organization
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
Conditions
Interventions
Aged Garlic Extract
NR
Locations (2)
Hadassah Medical Organization,
Jerusalem, Israel
Hadassah Medical Organization
Jerusalem, Israel