PeriodontitisNCT06287424
The Efficacy Of AGE On Periodontitis
A study testing Aged Garlic Extract in people with Periodontitis, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- 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
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Apr 2021to 1 Jan 2023
- 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 30-60 years;
- be in good general health as determined by the Investigator/designee based on a review of the medical history/update for participation in the study;
- possess a minimum of 16 natural teeth (excluding third molars) with facial and lingual scorable surfaces;
- have at least 20 bleeding sites (sum of sites with a score of 1 or 2 on the GBI index);
- have at least: 3 eligible periodontal pockets sites (PPD 3.5-6 mm, bleeding);
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- 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 (subject will be allowed to continue using floss but they will be instructed not to add/change any other oral hygiene products, including whitening products etc);
- 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 a new severe recession;
- active treatment for periodontitis;
- having a medical condition requiring antibiotic pre-medication prior to dental procedures,
- fixed facial or lingual orthodontic appliances or removable partial dentures;
- antibiotic or chlorhexidine use or anti-inflammatory 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
1 site in 1 country.
About this study
Official title: An Exploratory Eighteen Month Clinical Study To Evaluate Efficacy Of AGE Product On Periodontitis, A Dose Response Study
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.
Read the detailed 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.
- Conditions
- Periodontitis
- Being tested
- Aged Garlic Extract, Placebo
- Keywords
- Garlic, Periodontitis, Gingival Bleeding
- Medical subject headings
- Periodontitis, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aged Garlic ExtractDietary supplement
Subjects will be instructed to continue using their regular home oral hygiene products until the Product Distribution Visit (Visit 2). They will also be instructed not to add or change any of their regular home oral hygiene products during that time.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A: 4 tablet per day | Experimental | • Group A: Daily use of Aged Garlic Extract product: Take two (2) tablets with a meal twice daily.
The label is:
Garlic extract tablets for research - for research use only Instructions for use: Take (2) tablets immediately after breakfast and (2) tablets immediately after dinner every day.
Storage: Store in a cool, dry place with the lid tightly closed. Expiration date: August 2022 Please return empty bottles and excess tablets as requested. Receives: Dietary Supplement: Aged Garlic Extract |
| B: 6 tablet per day | Experimental | • Group B: Daily use of Aged Garlic Extract product: Take three (3) tablets with a meal twice daily.
The label is:
Garlic extract tablets for research - for research use only Instructions for use: Take (3) tablets immediately after breakfast and (3) tablets immediately after dinner every day.
Storage: Store in a cool, dry place with the lid tightly closed. Expiration date: August 2022 Please return empty bottles and excess tablets as requested. Receives: Dietary Supplement: Aged Garlic Extract |
| C: 8 tablet per day | Experimental | • Group C: Daily use of Aged Garlic Extract product: Take four (4) tablets with a meal twice daily.
The label is:
Garlic extract tablets for research - for research use only Instructions for use: Take (4) tablets immediately after breakfast and (4) tablets immediately after dinner every day.
Storage: Store in a cool, dry place with the lid tightly closed. Expiration date: August 2022 Please return empty bottles and excess tablets as requested. Receives: Dietary Supplement: Aged Garlic Extract |
| D: Placebo | Placebo comparator | • Group C: Daily use of Aged Garlic Extract product: Take four (4) tablets with a meal twice daily.
The label is:
Garlic extract tablets for research - for research use only Instructions for use: Take (4) tablets immediately after breakfast and (4) tablets immediately after dinner every day.
Storage: Store in a cool, dry place with the lid tightly closed. Expiration date: August 2022 Please return empty bottles and excess tablets as requested. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Bleeding Index (GBI)
The gingiva should be lightly air-dried and a periodontal probe with a 0.5 mm diameter tip inserted into the gingival crevice to a depth of 2mm or until slight resistance is felt. The probe is then run gently around the tooth at an angle of approximately 60° and in contact with the sulcular epithelium. Minimum axial force is used to avoid undue penetration into the tissue and the probe is moved around the crevice, gently stretching the epithelium. Each of the 3 gingival areas, i.e., buccal, mesial and lingual, of the teeth will be probed in this manner waiting approximately 30 seconds before recording the number of gingival units which bleed
Measured: Baseline, 6 Month, 12 Month, 18 Month
Probing Pocket Depth (PPD)
Probing Pocket Depth at every site will be assessed as the distance from the gingival margin to the apical end of the pocket using a WHO CPI probe. The probe will be inserted parallel to the root surface and directed apically toward the perceived location of the apex of the root until slight resistance is felt. Probe recordings will be rounded off to the nearest millimeter mark.
Measured: Baseline, 12 Month, 18 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start4 Apr 2021
- Primary completion30 Sep 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- 4 Regimen parralel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287424
- Sponsor's protocol ID
- HMO-2O-0536
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Eighteen Month Clinical Study To Evaluate Efficacy Of AGE Product On Periodontitis, A Dose Response Study
- ClinicalTrials.gov ID
- NCT06287424
- Acronym / sponsor ID
- HMO-2O-0536
- Conditions
- Periodontitis
- Keywords
- Garlic, Periodontitis, Gingival Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 1 Mar 2024 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 4 Regimen parralel groups
| Arm | Type | Receives |
|---|---|---|
| A: 4 tablet per day | Experimental | Dietary Supplement: Aged Garlic Extract• Group A: Daily use of Aged Garlic Extract product: Take two (2) tablets with a meal twice daily. The label is: Garlic extract tablets for research - for research use only Instructions for use: Take (2) tablets immediately after breakfast and (2) tablets immediately after dinner every day. Storage: Store in a cool, dry place with the lid tightly closed. Expiration date: August 2022 Please return empty bottles and excess tablets as requested. |
| B: 6 tablet per day | Experimental | Dietary Supplement: Aged Garlic Extract• Group B: Daily use of Aged Garlic Extract product: Take three (3) tablets with a meal twice daily. The label is: Garlic extract tablets for research - for research use only Instructions for use: Take (3) tablets immediately after breakfast and (3) tablets immediately after dinner every day. Storage: Store in a cool, dry place with the lid tightly closed. Expiration date: August 2022 Please return empty bottles and excess tablets as requested. |
| C: 8 tablet per day | Experimental | Dietary Supplement: Aged Garlic Extract• Group C: Daily use of Aged Garlic Extract product: Take four (4) tablets with a meal twice daily. The label is: Garlic extract tablets for research - for research use only Instructions for use: Take (4) tablets immediately after breakfast and (4) tablets immediately after dinner every day. Storage: Store in a cool, dry place with the lid tightly closed. Expiration date: August 2022 Please return empty bottles and excess tablets as requested. |
| D: Placebo | Placebo comparator | Dietary Supplement: Placebo• Group C: Daily use of Aged Garlic Extract product: Take four (4) tablets with a meal twice daily. The label is: Garlic extract tablets for research - for research use only Instructions for use: Take (4) tablets immediately after breakfast and (4) tablets immediately after dinner every day. Storage: Store in a cool, dry place with the lid tightly closed. Expiration date: August 2022 Please return empty bottles and excess tablets as requested. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- give written informed consent and receive a copy of their consent;
- be between the ages of 30-60 years;
- be in good general health as determined by the Investigator/designee based on a review of the medical history/update for participation in the study;
- possess a minimum of 16 natural teeth (excluding third molars) with facial and lingual scorable surfaces;
- have at least 20 bleeding sites (sum of sites with a score of 1 or 2 on the GBI index);
Key exclusion criteria (8 listed)
- • severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or a new severe recession;
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 ExtractSubjects will be instructed to continue using their regular home oral hygiene products until the Product Distribution Visit (Visit 2). They will also be instructed not to add or change any of their regular home oral hygiene products during that time. | Dietary supplement | A: 4 tablet per day, B: 6 tablet per day, C: 8 tablet per day |
| PlaceboPlacebo | Dietary supplement | D: Placebo |
Primary outcome
Gingival Bleeding Index (GBI)
Time frame: Baseline, 6 Month, 12 Month, 18 Month
The gingiva should be lightly air-dried and a periodontal probe with a 0.5 mm diameter tip inserted into the gingival crevice to a depth of 2mm or until slight resistance is felt. The probe is then run gently around the tooth at an angle of approximately 60° and in contact with the sulcular epithelium. Minimum axial force is used to avoid undue penetration into the tissue and the probe is moved around the crevice, gently stretching the epithelium. Each of the 3 gingival areas, i.e., buccal, mesial and lingual, of the teeth will be probed in this manner waiting approximately 30 seconds before recording the number of gingival units which bleed
Probing Pocket Depth (PPD)
Time frame: Baseline, 12 Month, 18 Month
Probing Pocket Depth at every site will be assessed as the distance from the gingival margin to the apical end of the pocket using a WHO CPI probe. The probe will be inserted parallel to the root surface and directed apically toward the perceived location of the apex of the root until slight resistance is felt. Probe recordings will be rounded off to the nearest millimeter mark.
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 1 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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, run by Hadassah Medical Organization at 1 site 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 10 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Gingival Bleeding Index (GBI) (time frame: Baseline, 6 Month, 12 Month, 18 Month). 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 1 Mar 2024.