Clinical trial NCT06287424: The Efficacy Of AGE On Periodontitis
Official title: An Exploratory Eighteen Month Clinical Study To Evaluate Efficacy Of AGE Product On Periodontitis, A Dose Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Garlic
Periodontitis
Gingival Bleeding
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Wakunaga Pharmaceutical Co., Ltd.
First posted: 2024-03-01
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 Regimen parralel groups
Primary purpose: PREVENTION

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.

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;

Primary outcomes:
measure: Gingival Bleeding Index (GBI)
timeFrame: Baseline, 6 Month, 12 Month, 18 Month
measure: Probing Pocket Depth (PPD)
timeFrame: Baseline, 12 Month, 18 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hebrew University
Study officials:
References: