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:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT04124068
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent to participate in the study.
* Be 18 to 65 years of age.
* Agree not to participate in any other oral/dental product studies during the trial.
* Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed.
* Agree to refrain from the use of any other teeth whitening products once assigned to a treatment group.
* Agree to refrain from the use of any oral care products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.).
* Agree to return for all scheduled visits and follow study procedures.
* 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.
* Have at least 4 gradable maxillary anterior teeth ( canine to canine) with a Vita Shade average score of C2 or darker.
* Be willing to refrain from consuming stain-causing food and beverages (i.e., coffee, tea, red wine, berries, etc.) during the initial treatment duration (treatment period excluding the 4 week follow up).
* Be a current or recent non-smoker (no smoking for at least 3 months).
Exclusion Criteria:
* Are undergoing treatment for gingivitis, periodontitis, or caries.
* Presence of self-reported tooth sensitivity.
* Present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
* Have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth ( canine to canine) or mandibular anterior teeth.
* Have any oral pathologies or gross neglect of home care requiring prompt treatment, including periodontal disease, as evidenced by purulent exudate, exposed root surfaces (generalized recession), tooth mobility, and/or other signs indicating that the integrity of the data collected for that subject might be compromised.
* Present with any pre-existing oral or medical condition that the Investigator/designee determines may place the subject at increased health risk from study participation.
* Have meaningful malocclusion that would impact treatment or ease of viewing/scoring maxillary anterior teeth.
* Have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypocalcification.
* Have any known allergies to over-the-counter oral hygiene/whitening products.
* Have any known allergies to the trial product ingredients.
* Are pregnant and/or breastfeeding.
* Are current smokers.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04124068
Study Brief:
Protocol Section:
NCT04124068