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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT04750005
Eligibility Criteria:
Inclusion Criteria:
* Able to read and understand (participants capable of reading the documents)
* Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)
* Negative pregnancy urine tests (females of childbearing potential only)
* Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study
* A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count
* A minimum of 10 percent (%) bleeding sites based on the expanded bleeding index (BI)
* Participants will have evidence of some gingivitis; there will be no minimum or maximum mean MGI score for gingivitis or TPI score for plaque; mild to severe gingivitis and mild to moderate periodontitis
* No more than 3 sites having pocket depths of 5 millimeter (mm) and no sites that are greater than 5 mm in depth
Exclusion Criteria:
* History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye; Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products)
* Dental prophylaxis within four weeks prior to Screening/Baseline visit
* History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
* Use of antibiotics, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
* Suspected alcohol or substance abuse (example., amphetamines, benzodiazepines, cocaine, marijuana, opiates
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04750005
Study Brief:
Protocol Section:
NCT04750005