An interventional study of Aged Garlic Extract in Periodontitis, Adult, sponsored by Hadassah Medical Organization. Completed at 2 sites in Israel. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Prevention
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.
Study Objective The objective of this study is to assess the long-term efficacy of "AGE among on periodontitis for a period of 2 years.
Overall Study Design and Plan 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 will be exited from the study and treated following local norms.
Screening/Baseline, Visit 1 Subjects will be asked to read and sign an informed consent and receive a signed copy. Personal medical history information will be reviewed and retained as site source documentation. A comprehensive oral examination (OST) will then be conducted to evaluate the oral and perioral region, including hard and soft tissues. Demographic information and study inclusion/exclusion criteria will be obtained and documented on the appropriate electronic case report form (CRF).
Then, subjects will receive MGI, GBI, CAL, and PPD assessments in that order by the experienced examiner. Subjects will be eligible to enroll in the study after meeting study entrance criteria.
Subjects will be instructed to continue using their regular home oral hygiene products until the Baseline visit. They will also be instructed not to add or change any of their regular home oral hygiene products during that time. Data will be reviewed and qualified subjects will be contacted and scheduled for their Baseline appointment. Those subjects will be asked to refrain from performing any oral hygiene procedures the morning prior to their scheduled Baseline visit and to refrain from using medicated lozenges, breath mints, eating, drinking (except for water), smoking and chewing gum for four (4) hours prior to their visit. The rest of the subjects will be released from the study, and a subject accountability form will be completed.
General Comments, if applicable, will be documented on the appropriate CRF. Product Distribution, Visit 2 Approximately maximum 1-2 weeks after the Screening/Baseline visit, subjects will return to the site and continuance criteria will be verified. Subjects will be randomized to a treatment group based on their Screening mean PPD, GBI, age, gender and tobacco use. Subjects will receive their assigned treatment products to use until their next appointment in the clinic (approximately 6 month later). AEs and General Comments, if applicable, will be documented. All data will be recorded electronically on the appropriate CRFs.
Approximately one week later, site staff not blinded to the products will re-connect to subjects via phone to ensure proper product usage and compliance.
Within one month from Baseline, subjects will receive a dental prophylaxis. Month-6, 12 Visit 3-4 Approximately 2 weeks before their scheduled visit, subjects will be contacted and reminded about their appointment. Subjects will also be reminded to bring their study products and to refrain from performing any oral hygiene procedures the morning prior to their next scheduled visit. In addition, they will be reminded to refrain from using medicated lozenges, breath mints, eating, drinking (except for water), smoking and chewing gum for four (4) hours prior to their next visit.
Subjects will return to the site (6 month from Baseline) and continuance criteria will be verified. Personal medical history information will be updated and retained as site source documentation.
A comprehensive oral examination will then be conducted to evaluate the oral and perioral region, including hard and soft tissues. Subjects will receive a MGI, GBI, CAL, and PPD assessment by the experienced examiner.
Following that, subjects will proceed to an area separated from the examination area to ensure blinding of the examiner to the identity of the test products and receive their supplemental kit box containing re-supply of their assigned treatment products. They will be asked to continue to use them for their daily oral hygiene twice per day until their next appointment in the clinic (approximately 6 month later). Instructions for home use and a reminder to comply with the study protocol will be given verbally by the site staff.
AEs and General Comments, if applicable, will be documented. All data will be recorded electronically on the appropriate CRFs.
Within one month from Month-6 visit, subjects will receive a dental prophylaxis.
Month-18, Visit 5 Approximately 2 weeks before their scheduled visit, subjects will be contacted and reminded about their appointment. Subjects will also be reminded to bring their study products and to refrain from performing any oral hygiene procedures the morning prior to their next scheduled visit. In addition, they will be reminded to refrain from using medicated lozenges, breath mints, eating, drinking (except for water), smoking and chewing gum for four (4) hours prior to their next visit.
Subjects will return to the site (18 month from Baseline) and continuance criteria will be verified. Personal medical history information will be updated and retained as site source documentation.
A comprehensive oral examination will then be conducted to evaluate the oral and perioral region, including hard and soft tissues. Subjects will receive a MGI, GBI, CAL, and PPD assessment by the experienced examiner.
AEs and General Comments, if applicable, will be documented. Subject accountability will be completed and subjects will be dismissed from the study. Subject accountability will also be completed for subjects who drop out of the study prior to its completion.
All data will be recorded electronically on the appropriate CRFs.
377 studies on the registry are indexed under Chronic Periodontitis; 21 are open to participants now.
This study's enrollment of 200 is above the median of 46 across 307 interventional studies indexed under Chronic Periodontitis.
Browse Chronic Periodontitis studies →Hadassah Medical Organization is the lead sponsor of 675 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Concentrated Aged Garlic Extract Microcrystalline Cellulose 133 mg Carboxymethylcellulose Calcium 6 mg Agar Powder 35 mg Silicon Dioxide 3.5 mg Calcium Stearate 3.5 mg Total Weight 307 mg
Dietary Supplement: Aged Garlic Extract
Microcrystalline Cellulose 258.55 mg Carboxymethylcellulose Calcium 6 mg Agar Powder 35 mg Coloring Agent 0.45 mg Details: Gardenia Extractive 44.5%, Corn Syrup 55% Potassium pyrophosphate 0.5% Silicon Dioxide 3.5 mg Calcium Stearate 3.5 mg Total Weight 307 mg
Dietary Supplement: Aged Garlic Extract
NR
Prevention of Gindivitis
A reduction of bleeding index in the Garlic group
Time frame: 4 months
Prevention of Gindivitis
A reduction of Gingival index in the Garlic group
Time frame: 4 months
Plan to share: No — the data will not be available to other researcher and will be save under personal password
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Sep 2019, 16 months.
Of 88 non-industry interventional studies with no phase under Chronic Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 24. This study's 16 months is close to that.
Counting every sponsor, half of 89 studies reached it within 15 months; a quarter within 10 and three quarters within 24.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 21, 2026: primary completion Apr 2018 → Sep 2019 and completion Apr 2020 → May 2020.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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