The Efficacy Of AGE On Periodontitis

NCT06287424 | Completed DMC

• 1 other identifier: HMO-2O-0536
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

Garlic; Periodontitis; Gingival Bleeding

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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.

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.

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.

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.

Dietary Supplement: Placebo

Interventions

Aged Garlic Extract 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.

A: 4 tablet per day; B: 6 tablet per day; C: 8 tablet per day

Placebo DIETARY_SUPPLEMENT

Placebo

D: Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Wakunaga Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Hebrew University

Jerusalem, 9112102, Israel

Location

MeSH Terms

Conditions

Periodontitis; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Gingival Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Eligible subjects will be stratified based on Screening mean PPD (above or below 2mm), mean GBI (above or below 0.44), mean age (above or below 45 years old), gender (male or female) and tobacco use (yes or no). Within strata, subjects will be randomly assigned to one of the treatment groups using an encoded program. This assignment process and the distribution of test products will be conducted in a protected area that will ensure blinding of the examiner to the identity of the test products.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 Regimen parralel groups

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 1, 2024
• Study Start: April 4, 2021
• Primary Completion: September 30, 2022
• Study Completion: January 1, 2023
• Last Updated: March 1, 2024

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)