CompletedPhase 4

A Clinical Study Assessing the Effects of a Marketed Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching

Canada90 participantsStarted 2024-10-07

Plain-language summary

The aim of this study is to investigate the efficacy of a marketed dentifrice containing 5 percent (%) NovaMin (Calcium Sodium Phosphosilicate) to reduce tooth sensitivity during and post tooth bleaching compared to a marketed dentifrice containing 5% potassium nitrate (KNO3) and a marketed regular fluoride-containing dentifrice.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Having no lesions of the teeth or oral cavity that could interfere with the study evaluations.
. At least a total of 11 of the facial surfaces of maxillary and mandibular anterior 6 teeth (tooth numbers 6-11 and 22-27) suitable for peroxide whitening and gradable for VITA Bleachedguide evaluation with no significant defects, calculus, restorations, crowns or veneers that could impact tooth bleaching performance or study evaluations as judged by the clinical examiner.
. A minimum of 16 natural teeth.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study

Timeframe: Up to Day 36

Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity

Timeframe: Up to Day 36

LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration

Timeframe: Up to Day 36

LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability

Timeframe: Upto Day 36

LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description

Timeframe: Up to Day 36

Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study

Timeframe: Up to Day 36

Number of Participants With a Tooth Sensitivity-free Day Through the Study

Trial details

NCT IDNCT06608368

SponsorHALEON

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-15

Results submitted2025-11-14

View on ClinicalTrials.gov More Dentin Sensitivity trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Having no lesions of the teeth or oral cavity that could interfere with the study evaluations.
. At least a total of 11 of the facial surfaces of maxillary and mandibular anterior 6 teeth (tooth numbers 6-11 and 22-27) suitable for peroxide whitening and gradable for VITA Bleachedguide evaluation with no significant defects, calculus, restorations, crowns or veneers that could impact tooth bleaching performance or study evaluations as judged by the clinical examiner.
. A minimum of 16 natural teeth.

What they're measuring

Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study

Timeframe: Up to Day 36

Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity

Timeframe: Up to Day 36

LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration

Timeframe: Up to Day 36

LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability

Timeframe: Upto Day 36

LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description

Timeframe: Up to Day 36

Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study

Timeframe: Up to Day 36

Number of Participants With a Tooth Sensitivity-free Day Through the Study