The Efficacy Of AGE On Periodontitis

NCT ID: NCT06287424

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-04
• Study Completion Date: 2023-01-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Aged Garlic Extract

Intervention Type: DIETARY_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.

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.

Group Type: EXPERIMENTAL

Aged Garlic Extract

Intervention Type: DIETARY_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.

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.

Group Type: EXPERIMENTAL

Aged Garlic Extract

Intervention Type: DIETARY_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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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;

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wakunaga Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hebrew University

Jerusalem, , Israel

Countries

Israel

Other Identifiers

HMO-2O-0536

Identifier Type: -

Identifier Source: org_study_id