Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT02543060
Eligibility Criteria:
Inclusion Criteria:
In order to be included in the study, each subject must:
* Provide written informed consent to participate in the study;
* Be 18 years of age or older;
* Agree not to participate in any other oral/dental product studies during the course of this study;
* Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
* Agree to maintain their current oral hygiene routine between the Screening and Baseline Visit and not to add/change their oral care products during this time;
* Agree to refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), including but not limited to the use of products such as floss or whitening products;
* Agree to return for all scheduled visits and follow study procedures;
* Must have at least 16 natural teeth;
* Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study;
* Agree to refrain from all oral hygiene for at least 12 hours prior to each visit;
* Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
* Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);
* Have minimum 3 sampling sites with bleeding and pocket depth ≥3mm but not deeper than 4mm;
* Have minimum 3 sampling sites without bleeding and with pocket depth ≤2mm.
Exclusion Criteria:
Subjects are excluded from study participation where there is evidence of:
* Have had a dental prophylaxis within 2 weeks of plaque sampling visits;
* Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
* Have rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
* Need an antibiotic prophylaxis prior to dental visits;
* A history of hypersensitivity to oral care products containing hydrogen peroxide;
* A history of hypersensitivity to dyes (from products containing food dyes);
* Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or
* Are pregnant (Self-reported) or lactating.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02543060
Study Brief:
Protocol Section:
NCT02543060