Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2021-07-14
2021-07-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Period 1
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)
0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Period 2
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)
0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Period 3
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)
0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Period 4
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)
0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Procter and Gamble
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oral Health Science Center
Mason, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021061
Identifier Type: -
Identifier Source: org_study_id