A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching

Study Overview
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Brief Summary
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The main aim of this study is to investigate the ability of an experimental dentifrice containing 5 percent (%) potassium nitrate (KNO3), 1% alumina and 5% sodium tripolyphosphate (STP), to maintain tooth color and reduce extrinsic dental stain accumulation following peroxide tooth bleaching compared to a regular fluoride dentifrice.

Detailed Description
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This will be a randomized, single-blind, single-center, controlled, two arm, stratified (clinically diagnosed dentine hypersensitivity [DH] [Yes/No]), parallel group study to evaluate the efficacy of an experimental dentifrice containing 5% KNO3, 1% alumina and 5% STP, to maintain tooth color and reduce the accumulation of extrinsic tooth stain following peroxide tooth bleaching compared to a regular fluoride-containing dentifrice. The study will recruit generally healthy participants who wish to undergo peroxide tooth bleaching. Sufficient participants will be screened to randomize approximately 160 participants to study treatment to ensure approximately 128 evaluable participants complete the study.

Official Title
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A Randomized, Controlled, Single-Blind Clinical Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching

Conditions
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Dentin Sensitivity, Oral Hygiene

Intervention / Treatment
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* Drug: Test Dentifrice
* Drug: Reference Dentifrice (Aquafresh Cavity Protection)


Participation Criteria
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Eligibility Criteria
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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 is willing and able to undergo at-home tooth bleaching with peroxide containing treatment unsupervised. Participant with generally good oral health that fulfil all of the following: Teeth suitable for peroxide bleaching and gradable for tooth color and suitable for MLSI evaluation with no significant defects, calculus, restorations, crowns or veneers that could impact peroxide tooth bleaching performance or study evaluations as judged by the clinical examiner. Facial surfaces of maxillary anterior 6 teeth (tooth numbers 6-11) [Universal tooth number system] with mean Vita Bleached guide shade greater than or equal to (>=)13 at Visits 1 and 2. Having no lesions of the teeth or oral cavity that could interfere with the study evaluations. Having 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 (self-reported) 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 bleaching treatment] (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 peroxide tooth bleaching procedure (either professionally dispensed or at-home [including peroxide-containing dentifrices]) within 12 months of Screening. Participant who has had a dental prophylaxis within 8 weeks of screening. Participant who has used tooth desensitizing treatment (for example dentifrice, mouthwash et cetera) within 2 weeks 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 study period, 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, tranquillizers, antidepressants, mood-altering and anti-inflammatory drugs). Participant will be allowed to use analgesics ad hoc to manage pain. Participant who has tooth abnormalities such as cracking or gross caries lesions that may, in the opinion of the investigator, impact the ability to evaluate tooth sensitivity. Participant who has previously been enrolled in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Dentifrice<br>Participants will dose the toothbrush provided with a strip of test dentifrice (5% KNO3, 1% alumina, 5% STP and 1150 parts per million [ppm] fluoride as sodium fluoride) and will brush for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice will be used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants will perform the first application of peroxide tooth bleaching as per the instructions provided and continue the application daily for up to 7 days. | Drug: Test Dentifrice<br>* Dentifrice containing 5% weight by weight (w/w) KNO3, 1% alumina, 5% STP and 1150 ppm fluoride as sodium fluoride.<br>|
| Active Comparator: Reference Dentifrice<br>Participants will dose the toothbrush provided with a strip of reference dentifrice (dentifrice containing 1150 ppm fluoride as sodium fluoride) and will brush for two timed minutes twice daily (morning and evening) for up to 27 weeks (dentifrice will be used for 2 weeks pre peroxide, 1 week during peroxide and 24 weeks post peroxide application). At Week 3, participants will perform the first application of peroxide tooth bleaching as per the instructions provided and continue the application daily for up to 7 days. | Drug: Reference Dentifrice (Aquafresh Cavity Protection)<br>* Dentifrice containing 1150 ppm fluoride as sodium fluoride.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean VITA Shade Score at 24 Weeks After Tooth Bleaching | Tooth color of the facial surfaces of the six anterior maxillary 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, where lower score indicates improvement. | At Week 24 after tooth bleaching | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean VITA Shade Score at 12 Weeks After Tooth Bleaching | Tooth color of the facial surfaces of the six anterior maxillary 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, where lower score indicates improvement. | At Week 12 after tooth bleaching | 
| Mean Total Modified Lobene Stain Index (MLSI) Score at 12 and 24 Weeks After Tooth Bleaching | Extrinsic dental stain will be assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Area (A) and intensity (I) of extrinsic dental stain will be scored separately for each tooth on the scale of 0 to 3 and the mean total score will be presented, where 0=area with no stain, 1=Stain covering up to one third of area and light intensity stain, 2=Stain covering up to two thirds of area and moderate intensity stain, 3=Stain covering more than two thirds of area and heavy intensity stain. Total MLSI score = Area score multiplied by Intensity score and ranges from 0 to 9, where lower score indicates improvement. | At Week 12 and Week 24 after tooth bleaching | 
| Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites | Extrinsic dental stain will be assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. The facial surface of each assessable tooth is divided into individual sites. The gingival site is defined as a crescent-shaped band, approximately 2 millimeters wide, adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. The remainder of the tooth surface is called as body site. Area (A) and intensity (I) of extrinsic dental stain will be scored separately for each tooth on the scale of 0 to 3 and the mean score will be presented, where 0=area with no stain, 1=Stain covering up to one third of area and light intensity stain, 2=Stain covering up to two thirds of area and moderate intensity stain, 3=Stain covering more than two thirds of area and heavy intensity stain. Total MLSI score = Area score multiplied by Intensity score and ranges from 0 to 9, where lower score indicates improvement. | At Week 12 and Week 24 after tooth bleaching | 
| Mean MLSI (Area) Score at 12 and 24 Weeks After Tooth Bleaching | Extrinsic dental stain will be assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Area (A) of extrinsic dental stain will be scored separately for each tooth on the scale of 0 to 3, where 0=area with no stain, 1=Stain covering up to one third of area, 2=Stain covering up to two thirds of area, 3=Stain covering more than two thirds of area. Total score ranges from 0 to 3, where lower score indicates improvement. | At Week 12 and Week 24 after tooth bleaching | 
| Mean MLSI (Intensity) Score at 12 and 24 Weeks After Tooth Bleaching | Extrinsic dental stain will be assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Intensity (I) of extrinsic dental stain will be scored separately for each tooth on the scale of 0 to 3, where 0=no stain, 1=light intensity stain, 2=moderate intensity stain, 3=heavy intensity stain. Total score ranges from 0 to 3, where lower score indicates improvement. | At Week 12 and Week 24 after tooth bleaching |