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Completed

NCT Number: NCT06608368

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

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.

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Key information

Conditions

Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

All Sum Research

Mississauga, Ontario, L5N 6J2, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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.

Treatment and study plan

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.

Positive Control Dentifrice (Sensodyne Fresh Mint)

Drug

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

Reference Dentifrice (Crest Cavity Protection Regular)

Drug

Dentifrice containing 1100 ppm fluoride as sodium fluoride.

Primary outcomes

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

    Time frame: Up to Day 36

    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.

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

    Time frame: Up to Day 36

    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.

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

    Time frame: Up to Day 36

    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.

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

    Time frame: Upto Day 36

    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.

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

    Time frame: Up to Day 36

    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.

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

    Time frame: Up to Day 36

    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.

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

    Time frame: Up to Day 36

    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.

  8. Number of Participants Who Use Analgesics to Alleviate Tooth Sensitivity

    Time frame: Up to Day 36

    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.

Secondary outcomes

  1. Mean VAS Score During Tooth Bleaching

    Time frame: Day 15 up to Day 21

    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 that they felt tooth sensitivity completed the remainder of the questionnaire and rated their overall tooth sensitivity using a 100 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.

  2. Mean LMS Score During Tooth Bleaching

    Time frame: Day 15 up to Day 21

    The tooth sensitivity questionnaire including the LMS 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 the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 mm LMS. Each individual scale was labelled with descriptive words related to the intensity, duration, tolerability, quality of tooth sensitivity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked each 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.

  3. Mean Bothersomeness NRS Score During Tooth Bleaching

    Time frame: Day 15 up to Day 21

    The tooth sensitivity questionnaire 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 were 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.

  4. Mean Percentage of Tooth Sensitivity-free Days During Tooth Bleaching

    Time frame: Day 15 up to Day 21

    The tooth sensitivity questionnaire was 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 were reported.

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

    Time frame: Day 15 up to Day 21

    The tooth sensitivity questionnaire was used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days (derived for each participant) during tooth bleaching where participants reported the use of analgesics to relieve tooth sensitivity/pain in the tooth sensitivity questionnaire were reported.

  6. Mean VAS Score Post Completion of Tooth Bleaching

    Time frame: Day 22 up to Day 36

    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 that they felt tooth sensitivity completed the remainder of the questionnaire and rated their overall tooth sensitivity using a 100 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.

  7. Mean LMS Score Post Completion of Tooth Bleaching

    Time frame: Day 22 up to Day 36

    The tooth sensitivity questionnaire including the LMS 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 the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 mm LMS. Each individual scale was labelled with descriptive words related to the intensity, duration, tolerability, quality of tooth sensitivity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked each 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.

  8. Mean Bothersomeness NRS Score Post Completion of Tooth Bleaching

    Time frame: Day 22 up to Day 36

    The tooth sensitivity questionnaire 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 were 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.

  9. Mean Percentage of Tooth Sensitivity-free Days Post Completion of Tooth Bleaching

    Time frame: Day 22 up to Day 36

    The tooth sensitivity questionnaire was 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 were reported.

  10. Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity Post Completion of Tooth Bleaching

    Time frame: Day 22 up to Day 36

    The tooth sensitivity questionnaire was used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days (derived for each participant) during tooth bleaching where participants reported the use of analgesics to relieve tooth sensitivity/pain in the tooth sensitivity questionnaire were reported.

  11. Change From Pre to Post-tooth Bleaching in Mean VITA Shade Score

    Time frame: 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 were assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER. VITA Bleachedguide 3D-MASTER uses a value-ranked ordered scale from 1 (the lightest) to 29 (the darkest). The shade level of each tooth surface was scored visually by the clinical examiner with reference to the Bleachedguide. Lower scores indicated an improvement.

Sponsors and collaborators

Lead sponsor

HALEON

Industry

Registry information

Official study title

A Randomized, Controlled Clinical Study Assessing the Effects of a Marketed Dentifrice Compared to a Regular Fluoride Dentifrice and a Positive Control Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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