Non-fluoride Whitening Toothpaste for Tooth Discoloration

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a non-fluoride whitening toothpaste to compare its stain-removal effectiveness against a regular fluoride toothpaste. The goal is to determine if the whitening toothpaste brightens smiles more effectively over an 8-week period. It suits individuals who brush daily, drink tea or coffee regularly, and wish to try a new whitening option. Participants must avoid other whitening products during the trial. As an unphased trial, this study provides a unique opportunity to explore new dental care options without the constraints of traditional clinical trial phases.

Do I need to stop taking my current medications for the trial?

Yes, if your current medications might affect oral tissue condition, salivation, or stain formation, you may need to stop taking them to participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown limited information about the safety of over-the-counter whitening products. Some studies have found these products more effective at whitening than regular toothpaste. However, information on their long-term safety remains scarce.

Users of these toothpastes might experience side effects such as sensitive teeth or irritated gums. The non-fluoride whitening toothpaste being tested has not been associated with serious problems, but individual reactions can vary.

Since this trial is not in its early stages, specific safety data for this product is limited. However, due to its similarity to other over-the-counter products, it is likely safe for most people. Consulting a dentist before trying new whitening treatments is advisable, especially if there are concerns about side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the non-fluoride whitening toothpaste because it offers a new approach to tackling tooth discoloration. Unlike standard whitening toothpastes, which typically rely on fluoride and abrasive agents to remove stains, this innovative toothpaste may use alternative ingredients to achieve whitening without fluoride, potentially making it a safer choice for those sensitive to fluoride or looking for a gentler option. This opens the door for broader use, including for individuals who prefer natural or non-fluoride dental care products, while still targeting and reducing tooth discoloration effectively.

What evidence suggests that this non-fluoride whitening toothpaste could be effective for tooth discoloration?

Research has shown that whitening toothpastes effectively remove surface stains from teeth. In this trial, participants will use either a non-fluoride whitening toothpaste or a non-whitening fluoride toothpaste. Studies have found that whitening products, including those without fluoride, often outperform regular toothpastes in removing discoloration. For instance, research found that whitening toothpastes consistently improved tooth color. However, some reviews suggest that their ability to deeply bleach teeth might be limited. In summary, non-fluoride whitening toothpastes can make teeth look whiter by removing stains, but their deep bleaching power remains uncertain.13456

Who Is on the Research Team?

JL

Jeffery L Milleman, DDS, MPA

Principal Investigator

Salus Research, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with tooth discoloration who are interested in testing the effectiveness of a non-fluoride whitening toothpaste compared to a non-whitening fluoride toothpaste over 8 weeks. The specific eligibility criteria have not been provided.

Inclusion Criteria

Be able to understand and sign the Informed Consent, complete a Medical History form, understand and comply with all study directions, and be available for all exam periods
Present with adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect) and continue to meet the inclusion criteria and not fall into the categories of exclusion during the period of the study
Have a mean Macpherson Modified Lobene Stain Index (MLSI) score of ≥ 1.5 on the labial surfaces of at least 8 of 12 anterior teeth
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Exclusion Criteria

Have a history of serious medical conditions or transmittable diseases including but not limited to active hepatitis, heart irregularities, conditions requiring pre-medication for dental procedures, rheumatic heart disease, untreated diabetes mellitus, cirrhosis, leukemia, phenylketonuria, renal disease, sarcoidosis, tuberculosis, bleeding disorder, vascular disease, AIDS, history of drug allergies or idiosyncrasies, or any other medical condition that may preclude successful participation in the trial, at the discretion of the Study Examiner
Have had prior significant adverse effects following the use of oral hygiene products
Have the presence of orthodontic bands, retainers, fixed appliances, large restorations, or removable partial dentures, which may interfere with clinical assessments of the evaluable teeth
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either a non-fluoride whitening toothpaste or a non-whitening fluoride toothpaste for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Non-fluoride Whitening Toothpaste
  • Non-whitening Fluoride Toothpaste
Trial Overview The study is testing two types of toothpaste: one that is a non-fluoride whitening formula, and another that contains fluoride but does not whiten teeth. Participants will use their assigned toothpaste without supervision for 8 weeks to see which improves tooth whiteness better.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Whitening ToothpasteExperimental Treatment1 Intervention
Group II: Non-Whitening ToothpastePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boka LLC

Lead Sponsor

Citations

NCT07219342 | The Purpose of This Research Study is ...The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening Toothpaste (Test) to That of a Non-whitening ...
Non-fluoride Whitening Toothpaste for Tooth DiscolorationThis trial is for individuals with tooth discoloration who are interested in testing the effectiveness of a non-fluoride whitening toothpaste ...
Effect of Whitening dentifrice on discoloration of tooth surfaceWhitening dentifrices consistently demonstrated superior efficacy in reducing tooth surface discoloration compared to regular dentifrices. The ...
Comparative Analysis of Whitening Outcomes of Over-the- ...The over-the-counter toothpaste used in this study showed effective teeth-whitening. Charcoal-based toothpaste showed the highest efficiency in teeth whitening.
Effectiveness and Adverse Effects of Over-the-Counter ...The main findings from the evaluated studies show little evidence that whitening dentifrices and rinses promote a real bleaching effect regardless of the ...
Effectiveness and Safety of Over-the-Counter Tooth ...In general, there is low evidence regarding the effectiveness and safety of OTC teeth-whitening agents [2,33]. A recent meta-analysis compared ...
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