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

Phase 4

Completed

• Conditions: Dentin Sensitivity
• Interventions: Drug: Test Dentifrice (Sensodyne Repair and Protect Original Mint); Drug: Positive Control Dentifrice (Sensodyne Fresh Mint); Drug: Reference Dentifrice (Crest Cavity Protection Regular)

• Registration Number: NCT06608368
• Lead Sponsor: HALEON

Brief 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.

Detailed Description

This is a randomized, examiner blind, single-center, controlled, three arm, parallel group, proof-of-principal study to evaluate tooth sensitivity during and following a course of at-home tooth bleaching in participants with and without clinically confirmed dentine hypersensitivity (DH). The study will recruit generally healthy participants who wish to undergo peroxide tooth bleaching. Sufficient participants will be screened to randomize approximately 90 participants to study treatment (approximately 30 per treatment group).

Study Timeline

• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-19
• Study First Posted: 2024-09-23
• Study Start: 2024-10-07
• Status Verified: 2024-11
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.

• Participant is of either sex and any gender who, at the time of screening, is between the ages of 18-65 years, inclusive.

• Participant is willing and able to comply with scheduled visits, and other study procedures and restrictions.

• Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history (for example, a medical condition confirmed to be causing xerostomia), or upon oral examination, that would impact the participant's safety, wellbeing or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.

• Participant who wishes and is able to undergo at-home peroxide tooth bleaching.

• Participant with generally good oral health that fulfil all of the following:

  1. Having no lesions of the teeth or oral cavity that could interfere with the study evaluations.
  2. 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.
  3. A minimum of 16 natural teeth.

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Exclusion Criteria

• Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
• Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 60 days prior to study entry and/or during study participation.
• Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• Participant who is pregnant or intending to become pregnant over the duration of the study or who is breastfeeding.
• Participant with known or suspected intolerance or hypersensitivity to the study materials [including the peroxide whitening gel] (or closely related compounds) or any of their stated ingredients.
• Participant who, in the opinion of the investigator or medically qualified designee, has a condition that would impact on their safety or wellbeing or affect their ability to understand and follow study procedures and requirements or who should not participate in the study for other reasons.
• Participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
• Participant with a recent history (within the last year) of alcohol or other substance abuse.
• Participant with gross periodontal disease or who has had treatment for periodontal disease (including surgery) within 12 months of Screening or who has had scaling or root planning within 3 months of Screening.
• Participant who has had a tooth bleaching procedure (either professionally dispensed or at home) within 12 months of Screening.
• Participant with a fixed or removable partial prosthesis, multiple dental implants or orthodontic braces/bands or fixed retainer or togue/lip piercing which, in the opinion of the investigator, could impact study outcomes.
• During the period from screening till 2 weeks post completion of tooth bleaching, participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
• Participant who has previously been enrolled in this study.
• Participant who has used an oral care product indicated for the relief of DH or care of sensitive teeth within 8 weeks of Screening (participants will be required to verbally confirm the name of their current oral care products to enable site staff to verify the absence of known sensitivity ingredients).
• Participant who is taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
• Participant who has had dental prophylaxis within 4 weeks of Screening or who requires antibiotic prophylaxis for dental procedures.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Dentifrice	Test Dentifrice (Sensodyne Repair and Protect Original Mint)	Participants will dose the toothbrush provided with a strip of test dentifrice containing 5% weight by weight (w/w) NovaMin (Calcium Sodium Phosphosilicate) and 1040 parts per million (ppm) fluoride as sodium fluoride on each brushing occasion and will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days.
Positive Control Dentifrice	Positive Control Dentifrice (Sensodyne Fresh Mint)	Participants will dose the toothbrush provided with a strip of positive control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days.
Reference Dentifrice	Reference Dentifrice (Crest Cavity Protection Regular)	Participants will dose the toothbrush provided with a strip of reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) Score of Tooth Sensitivity Questionnaire Collected Through the Study	Up to Day 36	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and will rate their overall tooth sensitivity using a 100 millimeter (mm) VAS with scores ranging from 0 (No Sensitivity) to 100 (Extreme Sensitivity). Lower scores indicate an improvement in sensitivity.
Labelled Magnitude Scale (LMS) Score of Tooth Sensitivity Questionnaire Collected Through the Study	Up to Day 36	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and rate the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 mm LMS. Participants will mark each scale to indicate the best description of their sensitivity and the marked-off line segment will be measured in 'mm'. Lower scores indicate an improvement in sensitivity.
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study	Up to Day 36	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and will rate how bothered they have been by any tooth sensitivity (example twinges, pain, ache or other sensations in teeth) using the Bothersomeness NRS scale. The scale ranges from 1 (Not bothered at all) to 10 (Extremely bothered). Lower scores indicate an improvement in sensitivity.
Number of Participants who Experience Tooth Sensitivity	Up to Day 36	Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours as a Yes/No response in the tooth sensitivity questionnaire. Number of participants with 'Yes' response will be reported.
Number of Participants who Use Analgesics to Alleviate Tooth Sensitivity	Up to Day 36	Participants will indicate whether they have used any pain killing medications to relieve tooth sensitivity/pain in the last 24 hours as a Yes/No response in the tooth sensitivity questionnaire. Number of participants with 'Yes' response will be reported.

Secondary Outcome Measures

Name	Time	Method
Mean VAS Score During Tooth Bleaching	Day 15 up to Day 21	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and will rate their overall tooth sensitivity using a 100 mm VAS with scores ranging from 0 (No Sensitivity) to 100 (Extreme Sensitivity). Lower scores indicate an improvement in sensitivity.
Mean LMS Score During Tooth Bleaching	Day 15 up to Day 21	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and rate the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 mm LMS. Participants will mark each scale to indicate the best description of their sensitivity and the marked-off line segment will be measured in 'mm'. Lower scores indicate an improvement in sensitivity.
Mean Bothersomeness NRS Score During Tooth Bleaching	Day 15 up to Day 21	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and will rate how bothered they have been by any tooth sensitivity (example twinges, pain, ache or other sensations in teeth) using the Bothersomeness NRS scale. The scale ranges from 1 (Not bothered at all) to 10 (Extremely bothered). Lower scores indicate an improvement in sensitivity.
Percentage of Tooth Sensitivity-free Days During Tooth Bleaching	Day 15 up to Day 21	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days during tooth bleaching where participants reported no tooth sensitivity in the tooth sensitivity questionnaire will be reported.
Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity During Tooth Bleaching	Day 15 up to Day 21	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days during tooth bleaching where participants reported the use of analgesics to relieve tooth sensitivity/pain in the tooth sensitivity questionnaire will be reported.
Mean VAS Score Post Completion of Tooth Bleaching	Day 22 up to Day 36	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and will rate their overall tooth sensitivity using a 100 mm VAS with scores ranging from 0 (No Sensitivity) to 100 (Extreme Sensitivity). Lower scores indicate an improvement in sensitivity.
Mean LMS Score Post Completion of Tooth Bleaching	Day 22 up to Day 36	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and rate the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 mm LMS. Participants will mark each scale to indicate the best description of their sensitivity and the marked-off line segment will be measured in 'mm'. Lower scores indicate an improvement in sensitivity.
Mean Bothersomeness NRS Score Post Completion of Tooth Bleaching	Day 22 up to Day 36	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and will rate how bothered they have been by any tooth sensitivity (example twinges, pain, ache or other sensations in teeth) using the Bothersomeness NRS scale. The scale ranges from 1 (Not bothered at all) to 10 (Extremely bothered). Lower scores indicate an improvement in sensitivity.
Percentage of Tooth Sensitivity-free Days Post Completion of Tooth Bleaching	Day 22 up to Day 36	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days post completion of tooth bleaching where participants reported no tooth sensitivity in the tooth sensitivity questionnaire will be reported.
Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity Post Completion of Tooth Bleaching	Day 22 up to Day 36	The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days post completion of tooth bleaching where participants reported the use of analgesics to relieve tooth sensitivity/pain in the tooth sensitivity questionnaire will be reported.
Change from Pre to Post-tooth Bleaching in Mean VITA Shade Score	Day 15 (Pre-bleaching) up to Day 22 (Post-bleaching)	Tooth shade (color) of the facial surfaces of the anterior 6 maxillary and mandibular teeth will be assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER. It uses a value-ranked ordered scale from 1 (the lightest) to 29 (the darkest). The shade level of each tooth surface will be scored visually by the clinical examiner with reference to the Bleachedguide. Lower scores indicate an improvement.

Trial Locations

Locations (1)

All Sum Research; 🇨🇦 Mississauga, Ontario, Canada