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Completed

NCT Number: NCT06735235

Salivary Fluoride Clearance

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

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Key information

Conditions

Caries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oral Health Science Center

Mason, Ohio, 45040, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0 ppm F

Drug

Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.

250 ppm F as MFP

Drug

Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.

1100 ppm as MFP

Drug

Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.

2800 ppm F as MFP

Drug

Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.

Primary outcomes

  1. area under the curve (AUC)

    Time frame: 2-minutes, 6-minutes, 12-minutes, and 30-minutes

    The primary endpoint will be AUC of the fluoride levels from 2 to 30 minutes. AUC will be calculated for each subject and treatment combination by integrating a 3 parameter first order decay model curve estimate (y= theta1 * exp (-theta2.X) + theta3). For any values obtained for a timepoint that are below the detection limit, 0.5 times the detection limit will be used. The following rules will apply if a subject has missing value(s) before the AUC is calculated:

    • If 2 or more timepoints are missing within a period, then the AUC will be set to missing
    • If only 2-minute data are missing, then curve will be estimated as above
    • If 6-minute or 12-minute data are missing, a linear imputation between the adjacent timepoints will be used
    • If 30-minute data are missing, the 12-minute data will be carried forward.

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

Evaluation of Salivary Fluoride Clearance Following the Use of Three MFP-Containing Dentifrices

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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