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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT04155658
Eligibility Criteria:
Key Inclusion Criteria:
1. Be wearing a removable mandibular partial denture that fits comfortably enough to wear 24 hours a day and willing to have their partial denture modified to accommodate the enamel test specimens.
2. Have completed and been accepted into the Oral Health Research Institute's screening for partial denture panel (#110007150).
3. Have no current active caries or periodontal disease that may compromise the trial or health of the person. Persons exhibiting localized periodontal conditions who, in the opinion of the trial dentist, will not be negatively affected by participation in intra-oral studies may be accepted. Persons with caries may participate if the carious lesions have been restored prior to beginning the first treatment.
4. Be willing to comply with all subjects' responsibilities (be willing and capable of wearing their removable partial dentures 24 hours per day during the treatment periods, attend appointments, follow brushing instructions, use non zinc adhesive in upper denture only etc.).
5. Have an unstimulated salivary flow rate of at least 0.2 ml per minute as determined by a five-minute salivary flow test at screening and a stimulated salivary flow rate of at least 0.8 ml per minute as determined by a two-minute stimulated (gum base) salivary flow test at screening
Key Exclusion Criteria:
1. Currently pregnant, intending to become pregnant during the trial period or breast-feeding.
2. Have a history of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses.
3. Have any allergy to ingredients in the trial toothpaste products.
4. Currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning the first treatment.
5. Have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications\* that prohibit the safe conduct of a dental cleaning\* or previous use of the weight loss medications Fen Phen® or Redux®. \*Note: Subjects who are taking blood thinners in which written verification is obtained from their physician indicating their PT/INR levels (anti-coagulation blood levels) are at an acceptable level to avoid serious complications, such as bleeding during dental cleaning, may be accepted into the trial.
6. Currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
7. Currently taking fluoride supplements, required to use a fluoride mouth rinse or have received a professional fluoride treatment in the two weeks preceding specimen placement.
8. Participation in another clinical trial/study within 30 days preceding the present trial/study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04155658
Study Brief:
Protocol Section:
NCT04155658