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 range18 Years – 65 Years

SexALL

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

Timeframe: Up to Day 36

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 range18 Years – 65 Years

SexALL

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

Timeframe: Up to Day 36