An interventional study of Aged Garlic Extract and Placebo in Periodontitis, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Prevention
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 300 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or a new severe recession;
• 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.
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.
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.
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.
Dietary Supplement: Placebo
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.
Placebo
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
Time frame: 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.
Time frame: Baseline, 12 Month, 18 Month
Plan to share: No
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization