Clinical trial NCT06608368: A Clinical Study Assessing the Effects of a Marketed Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dentin Sensitivity
Lead sponsor: HALEON
Sponsor class: INDUSTRY
First posted: 2024-09-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Visual Analogue Scale (VAS) Score of Tooth Sensitivity Questionnaire Collected Through the Study
timeFrame: Up to Day 36
measure: Labelled Magnitude Scale (LMS) Score of Tooth Sensitivity Questionnaire Collected Through the Study
timeFrame: Up to Day 36
measure: Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study
timeFrame: Up to Day 36
measure: Number of Participants who Experience Tooth Sensitivity
timeFrame: Up to Day 36
measure: Number of Participants who Use Analgesics to Alleviate Tooth Sensitivity
timeFrame: Up to Day 36
Secondary outcomes:
measure: Mean VAS Score During Tooth Bleaching
timeFrame: Day 15 up to Day 21
measure: Mean LMS Score During Tooth Bleaching
timeFrame: Day 15 up to Day 21
measure: Mean Bothersomeness NRS Score During Tooth Bleaching
timeFrame: Day 15 up to Day 21
measure: Percentage of Tooth Sensitivity-free Days During Tooth Bleaching
timeFrame: Day 15 up to Day 21
measure: Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity During Tooth Bleaching
timeFrame: Day 15 up to Day 21
measure: Mean VAS Score Post Completion of Tooth Bleaching
timeFrame: Day 22 up to Day 36
measure: Mean LMS Score Post Completion of Tooth Bleaching
timeFrame: Day 22 up to Day 36
measure: Mean Bothersomeness NRS Score Post Completion of Tooth Bleaching
timeFrame: Day 22 up to Day 36
measure: Percentage of Tooth Sensitivity-free Days Post Completion of Tooth Bleaching
timeFrame: Day 22 up to Day 36
measure: Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity Post Completion of Tooth Bleaching
timeFrame: Day 22 up to Day 36
measure: Change from Pre to Post-tooth Bleaching in Mean VITA Shade Score
timeFrame: Day 15 (Pre-bleaching) up to Day 22 (Post-bleaching)
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: All Sum Research
state: Ontario
Study officials:
References: