The Efficacy Of AGE On Periodontitis

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Aged Garlic Extract

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 9112102
    • Hebrew University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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);
• 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;

Exclusion Criteria:

• • 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: 4 tablet per day; • 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; 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.
Experimental: B: 6 tablet per day; • 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; 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.
Experimental: C: 8 tablet per day; • 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; 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 Comparator: D: 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.	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline, 12 Month, 18 Month

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Wakunaga Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Garlic; Periodontitis; Gingival Bleeding
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: HMO-2O-0536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No