- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06150573
A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching
April 17, 2024 updated by: HALEON
A Randomized, Controlled, Single-Blind Clinical Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haleon Response Center
- Phone Number: +441932 95 95 00
- Email: ww.clinical-trial-register@haleon.com
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89146
- Silverstone Research Group
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Contact:
- Pejmon Amini, DDS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Dentifrice
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.
|
Dentifrice containing 5% weight by weight (w/w) KNO3, 1% alumina, 5% STP and 1150 ppm fluoride as sodium fluoride.
|
Active Comparator: Reference Dentifrice
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.
|
Dentifrice containing 1150 ppm fluoride as sodium fluoride.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean VITA Shade Score at 24 Weeks After Tooth Bleaching
Time Frame: At Week 24 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
Time Frame: At Week 12 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
Time Frame: At Week 12 and Week 24 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
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Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites
Time Frame: At Week 12 and Week 24 after tooth bleaching
|
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
Time Frame: At Week 12 and Week 24 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
Time Frame: At Week 12 and Week 24 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2023
Primary Completion (Estimated)
July 19, 2024
Study Completion (Estimated)
July 19, 2024
Study Registration Dates
First Submitted
November 21, 2023
First Submitted That Met QC Criteria
November 21, 2023
First Posted (Actual)
November 29, 2023
Study Record Updates
Last Update Posted (Actual)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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