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

NCT06608368 | Completed Phase 4 Results

• 1 other identifier: 300106
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (8)

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

  The tooth sensitivity questionnaire including the VAS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated their overall tooth sensitivity using a 100 millimeter (mm) VAS with scores ranging from 0 mm (No Sensitivity) to 100 mm (Extreme Sensitivity). Participants made a single vertical mark at the point on the scale which represented the degree of overall tooth sensitivity (example twinges, pain and other sensations in their teeth) that they experienced over the last 24 hours. The marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.

  Up to Day 36

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

  The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a Yes response completed the remainder of the questionnaire and rated the intensity of their tooth sensitivity using the individual 100 mm LMS for intensity. The scale was labelled with descriptive words related to intensity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the intensity of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.

  Up to Day 36

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

  The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a Yes response completed the remainder of the questionnaire and rated the duration of their tooth sensitivity using the individual 100 mm LMS for duration. The scale was labelled with descriptive words related to duration and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the duration of sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.

  Up to Day 36

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

  The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a 'Yes' response completed the remainder of the questionnaire and rated the tolerability of their tooth sensitivity using the individual 100 mm LMS for tolerability. The scale was labelled with descriptive words related to tolerability and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the tolerability of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.

  Upto Day 36

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

  The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a 'Yes' response completed the remainder of the questionnaire and rated the tolerability of their tooth sensitivity using the individual 100 mm LMS for description. The scale was labelled with descriptive words related to the quality of tooth sensitivity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.

  Up to Day 36

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

  The tooth sensitivity questionnaire including Bothersomeness NRS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated how bothered they had been by any tooth sensitivity (example twinges, pain, ache or other sensations in teeth) using the Bothersomeness NRS scale. The scale ranged from 1 (Not bothered at all) to 10 (Extremely bothered). Lower scores indicated an improvement in sensitivity.

  Up to Day 36

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

  Participants indicated whether they felt tooth sensitivity during the previous 24 hours as a Yes/No response in the tooth sensitivity questionnaire. Number of participants with 'No' response were reported.

  Up to Day 36

• Number of Participants Who Use Analgesics to Alleviate Tooth Sensitivity

  Participants indicated whether they 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 were to be reported.

  Up to Day 36

Secondary Outcomes (11)

• Mean VAS Score During Tooth Bleaching

  Day 15 up to Day 21

• Mean LMS Score During Tooth Bleaching

  Day 15 up to Day 21

• Mean Bothersomeness NRS Score During Tooth Bleaching

  Day 15 up to Day 21

• Mean Percentage of Tooth Sensitivity-free Days During Tooth Bleaching

  Day 15 up to Day 21

• Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity During Tooth Bleaching

  Day 15 up to Day 21

Study Arms (3)

Test Dentifrice

EXPERIMENTAL

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.

Drug: Test Dentifrice (Sensodyne Repair and Protect Original Mint)

Positive Control Dentifrice

ACTIVE COMPARATOR

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.

Drug: Positive Control Dentifrice (Sensodyne Fresh Mint)

Reference Dentifrice

ACTIVE COMPARATOR

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.

Drug: Reference Dentifrice (Crest Cavity Protection Regular)

Interventions

Test Dentifrice (Sensodyne Repair and Protect Original Mint) DRUG

Dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride.

Test Dentifrice

Positive Control Dentifrice (Sensodyne Fresh Mint) DRUG

Dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride.

Positive Control Dentifrice

Reference Dentifrice (Crest Cavity Protection Regular) DRUG

Dentifrice containing 1100 ppm fluoride as sodium fluoride.

Reference Dentifrice

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

All Sum Research

Mississauga, Ontario, L5N 6J2, Canada

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+441932959500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: October 7, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: December 15, 2025
• Results First Posted: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Locations

CA (1)