Periodontitis, AdultNCT03492723
Garlic Product Impact on Periodontitis (GPIP)
A study testing Aged Garlic Extract in people with Periodontitis, Adult, run by Hadassah Medical Organization at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- Aged Garlic Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesIsrael
- Study dates
- 17 Apr 2018to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- give written informed consent and receive a copy of their consent
- be between the ages of 30 to 60 years
- be in good general health as determined by the Investigator or designee
- based on a review of the medical history or update for participation in the study
- possess a minimum of 16 natural teeth with facial and lingual scorable surfaces
- have at least 20 bleeding sites
Show all 11Show fewer
- have at least 3 eligible periodontal sites
- agree to delay any elective dentistry until study completion, including additional dental prophylaxes outside the study protocol
- agree to refrain from using any non study oral hygiene products for the study duration
- agree not to participate in any other oral care clinical study for the duration of this study
- agree to return for their scheduled visits and follow study procedures
Who cannot join
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and or severe recession
- active treatment for periodontitis
- having a medical condition requiring antibiotic premedication prior to dental procedures,
- fixed facial or lingual orthodontic appliances or removable partial dentures
- antibiotic or chlorhexidine use or antiinflammatory medications within two weeks prior to Screening visit
- self report nursing, pregnancy, or intent to become pregnant during the study
- dental prophylaxis within two month prior to the Screening visit
- any diseases or conditions that could be expected to interfere with the subject safely completing the study
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Organization,
Jerusalem, 91120
Hadassah Medical Organization
Jerusalem, 91120
About this study
Official title: Placebo-Control, Randomized, Double Blind Long Term Trial to Evaluate the Efficacy of Garlic Product on Periodontitis
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Periodontitis, Adult
- Being tested
- Aged Garlic Extract
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aged Garlic ExtractDietary supplement
NR
| Study group | Role | What they receive |
|---|---|---|
| garlic groupe | Experimental | 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 Receives: Dietary Supplement: Aged Garlic Extract |
| placebo groupe | Placebo comparator | 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 Receives: Dietary Supplement: Aged Garlic Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of Gindivitis
A reduction of bleeding index in the Garlic group
Measured: 4 months
Prevention of Gindivitis
A reduction of Gingival index in the Garlic group
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start17 Apr 2018
- Primary completion10 Sep 2019
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, controlled, examiner-blind, 2-treatment parallel group study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Mann, DMD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492723
- Sponsor's protocol ID
- 0114-17-HMO-CTIL
- Status last verified
- Feb 2021
- First submitted
- 29 Mar 2018
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data will not be available to other researcher and will be save under personal password
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Control, Randomized, Double Blind Long Term Trial to Evaluate the Efficacy of Garlic Product on Periodontitis
- ClinicalTrials.gov ID
- NCT03492723
- Acronym / sponsor ID
- 0114-17-HMO-CTIL
- Conditions
- Periodontitis, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, examiner-blind, 2-treatment parallel group study.
| Arm | Type | Receives |
|---|---|---|
| garlic groupe | Experimental | Dietary Supplement: Aged Garlic ExtractConcentrated 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 |
| placebo groupe | Placebo comparator | Dietary Supplement: Aged Garlic ExtractMicrocrystalline 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- give written informed consent and receive a copy of their consent
- be between the ages of 30 to 60 years
- be in good general health as determined by the Investigator or designee
- based on a review of the medical history or update for participation in the study
- possess a minimum of 16 natural teeth with facial and lingual scorable surfaces
Key exclusion criteria (8 listed)
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and or severe recession
- active treatment for periodontitis
- having a medical condition requiring antibiotic premedication prior to dental procedures,
- fixed facial or lingual orthodontic appliances or removable partial dentures
- antibiotic or chlorhexidine use or antiinflammatory medications within two weeks prior to Screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aged Garlic ExtractNR | Dietary supplement | garlic groupe, placebo groupe |
Primary outcome
Prevention of Gindivitis
Time frame: 4 months
A reduction of bleeding index in the Garlic group
Prevention of Gindivitis
Time frame: 4 months
A reduction of Gingival index in the Garlic group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. the data will not be available to other researcher and will be save under personal password
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Mann, DMD principal investigator
Hadassah Medical Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aged Garlic Extract in people with Periodontitis, Adult, run by Hadassah Medical Organization at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of Gindivitis (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.