Clinical trial NCT06735235: Salivary Fluoride Clearance
Official title: Evaluation of Salivary Fluoride Clearance Following the Use of Three MFP-Containing Dentifrices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Caries
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2024-12-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single-center, four-treatment, four-period crossover study. Over the course of the study, up to thirty qualified subjects will use four (4) study treatment products, one time each according to the randomization. Subjects will brush with 1.25g of the assigned study product at each visit. Subjects will provide saliva samples at baseline and at 2, 6, 12, and 30 minutes post-treatment. The F- concentrations in each saliva sample will be determined by ion chromatography


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to study participation and be given a signed copy of the Informed Consent form;
* Be in good general health as determined by the Investigator/Designee based on a review of their medical history;
* Have at least 16 natural teeth;
* Have normal salivary flow (0.3-0.6 ml/min) or deemed acceptable by the Investigator/Designee as determined in a previous screening outside of this protocol;
* Agree not to participate in any other oral care studies for the duration of this study;
* Agree not to change their current oral care routine except 1) to refrain from using mouth rinse and 2) to agree to use study washout product as designated (current floss users are permitted to continue to floss during this study); viii. Agree to delay elective dentistry, including dental prophylaxis, until study completion, and to report any non-study dentistry received during the course of the study;
* Agree to refrain from eating, using breath mints, using medicated lozenges, chewing gum, brushing their teeth or drinking within 2 hours of the visit, other than small sips of water up to 30 minutes prior to the visit;
* Agree to refrain from drinking tea or mineral water, and/or eating sardines within the 12 hours prior to the study visit; and
* Agree to return for all scheduled visits and to follow all study procedures.

Exclusion Criteria:

* Active treatment for gingivitis, periodontitis, or caries;
* Self-reported pregnancy or nursing;
* Smoking or tobacco chewing;
* Sjögren syndrome or any other disease/condition causing severe xerostomia;
* Kidney disease or renal impairment;
* Undergoing chemotherapy or irradiation procedures;
* Fixed orthodontic appliances that may interfere with product use;
* Inability to undergo any study procedures; or
* Any condition or disease, as determined by the Investigator/Designee that could be expected to interfere with examination procedures or with the subject's safe completion of the study

Primary outcomes:
measure: area under the curve (AUC)
timeFrame: 2-minutes, 6-minutes, 12-minutes, and 30-minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mason
country: United States
facility: Oral Health Science Center
state: Ohio
Study officials:
References: