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Completed
NCT03492723
Garlic Product Impact on Periodontitis (GPIP)
Conditions: Periodontitis, Adult
Sex: All
Ages: 30 Years – 60 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 200
Sponsor: Hadassah Medical Organization
Location: Hadassah Medical Organization, Jerusalem
Summary
This is a randomized, controlled, examiner-blind, 2-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 200 generally healthy adult volunteers with mild to moderate periodontitis.
Subjects will be stratified and randomly assigned equally to either the regimen group (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, 12, and 18 subjects will receive oral soft tissue exams, and will have gingival inflammation, bleeding, and periodontal measurements made as described in below.
Both groups will receive supragingival 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 to 60 years
* be in good general health as determined by the Investigator or designee
* based on a review of the medical history or update for participation in the study
* possess a minimum of 16 natural teeth with facial and lingual scorable surfaces
* have at least 20 bleeding sites
* have at least 3 eligible periodontal sites
* 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
* 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 severe recession
* active treatment for periodontitis
* having a medical condition requiring antibiotic premedication prior to dental procedures,
* fixed facial or lingual orthodontic appliances or removable partial dentures
* antibiotic or chlorhexidine use or antiinflammatory 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
Source: ClinicalTrials.gov (NCT03492723). StuddyBuddy aggregates publicly available trial information.