Garlic Product Impact on Periodontitis (GPIP)

NCT03492723 | Unknown

• 1 other identifier: 0114-17-HMO-CTIL
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Periodontitis, Adult

Outcome Measures

Primary Outcomes (2)

• Prevention of Gindivitis

  A reduction of bleeding index in the Garlic group

  4 months

• Prevention of Gindivitis

  A reduction of Gingival index in the Garlic group

  4 months

Study Arms (2)

garlic groupe

EXPERIMENTAL

Concentrated Aged Garlic Extract Microcrystalline Cellulose 133 mg Carboxymethylcellulose Calcium 6 mg Agar Powder 35 mg Silicon Dioxide 3.5 mg Calcium Stearate 3.5 mg Total Weight 307 mg

Dietary Supplement: Aged Garlic Extract

placebo groupe

PLACEBO COMPARATOR

Microcrystalline Cellulose 258.55 mg Carboxymethylcellulose Calcium 6 mg Agar Powder 35 mg Coloring Agent 0.45 mg Details: Gardenia Extractive 44.5%, Corn Syrup 55% Potassium pyrophosphate 0.5% Silicon Dioxide 3.5 mg Calcium Stearate 3.5 mg Total Weight 307 mg

Dietary Supplement: Aged Garlic Extract

Interventions

Aged Garlic Extract DIETARY_SUPPLEMENT

NR

garlic groupe; placebo groupe

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (2)

Hadassah Medical Organization,

Jerusalem, 91120, Israel

RECRUITING

Hadassah Medical Organization

Jerusalem, 91120, Israel

ENROLLING BY INVITATION

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Mann, DMD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avraham Zini, PhD; DMD

CONTACT

00 972 54 8820962; aviz@hadassah.org.il

Hadas Lamberg, PhD

CONTACT

00 972 2 6777572; lhadas@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: both, the participants and the investigators will be blind 2 groups will be assigned randomally
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, controlled, examiner-blind, 2-treatment parallel group study.

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 10, 2018
• Study Start: April 17, 2018
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2020
• Last Updated: April 17, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)