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:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT02207400
Eligibility Criteria:
Inclusion Criteria:
* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.
* A minimum of 20 permanent gradable teeth
* Moderate gingivitis present at the screening visit in the opinion of the investigator
* A total of 20 bleeding sites or greater at baseline visit
* Positive response to bleeding on brushing present at the screening visit
Exclusion Criteria:
* Pregnant or breast feeding women
* Tobacco chewers
* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participant or undermines the data validity.
* Recent history (within the last year) of alcohol or other substance abuse
* Participants requiring prophylactic antibiotic treatment prior to dental therapy
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
* Have current active caries or any medical conditions which may directly influence gingival bleeding
* Use of concomitant or any systemic medication that, in the opinion of the investigator, might interfere with the outcome of the study or have an effect on gingival conditions within 14 days of gingival examinations
* Excessive calculus present that interferes with the probing examination for Gingival Bleeding Index
* Participation in another clinical study or receipt of an investigational drug or oral care product within 30 days of the screening visit
* An employee of the sponsor or the study site or members or their immediate family.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02207400
Study Brief:
Protocol Section:
NCT02207400