Salivary Fluoride Clearance

Procter & Gamble (P&G)

Status and phase: Completed; Phase 1

Conditions: Caries

Treatments: Drug: 1100 ppm as MFP; Drug: 0 ppm F; Drug: 2800 ppm F as MFP; Drug: 250 ppm F as MFP

Study type: Interventional

Funder types: Industry

Identifiers

NCT06735235

2021061

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 4 patient groups

Period 1

Other group

Description:

0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)

Treatment:

Drug: 250 ppm F as MFP

Drug: 2800 ppm F as MFP

Drug: 0 ppm F

Drug: 1100 ppm as MFP

Period 2

Other group

Description:

0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)

Treatment:

Drug: 250 ppm F as MFP

Drug: 2800 ppm F as MFP

Drug: 0 ppm F

Drug: 1100 ppm as MFP

Period 3

Other group

Description:

0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)

Treatment:

Drug: 250 ppm F as MFP

Drug: 2800 ppm F as MFP

Drug: 0 ppm F

Drug: 1100 ppm as MFP

Period 4

Other group

Description:

0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)

Treatment:

Drug: 250 ppm F as MFP

Drug: 2800 ppm F as MFP

Drug: 0 ppm F

Drug: 1100 ppm as MFP