An interventional study of Whitening Toothpaste and Experimental Mouthwash in Tooth Discoloration, sponsored by HALEON. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by HALEON · Not applicable, Interventional, and Treatment
The aim of this clinical study is to evaluate the efficacy of an experimental mouthwash used with a marketed whitening toothpaste or a marketed regular fluoride toothpaste, compared to a marketed regular fluoride toothpaste alone, in preventing extrinsic dental stain build-up.
This will be a single-center, 12-week, randomized, controlled, examiner-blind, 3 treatment-arm, parallel-group, stratified clinical study in healthy participants to evaluate impact on the build-up of dental stain after 12 weeks twice daily use of an experimental mouthwash with either a marketed whitening toothpaste containing 5 percent (%) potassium nitrate (KNO3) and 0.25% sodium fluoride (NaF) or with a marketed regular fluoride toothpaste containing 0.25% NaF compared with use of a marketed regular fluoride toothpaste containing 0.25% NaF. Sufficient participants will be screened to ensure approximately 360 participants are randomized to treatment groups and approximately 342 participants complete the study (approximately 114 participants per treatment group).
105 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.
This study's planned enrollment of 360 is above the median of 48 across 97 interventional studies indexed under Tooth Discoloration.
Browse Tooth Discoloration studies →HALEON is the lead sponsor of 64 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At Visit 1 (Screening/Baseline):
Exclusion Criteria:
Participant using daily oral care products and/or taking daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with study outcomes, specifically:
Specific exclusions for assessment teeth:
General oral exclusions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will brush their teeth using a full ribbon of Whitening Toothpaste on head of toothbrush provided for two (timed) minutes, twice a day (morning and evening), for approximately 12 Weeks. After each brushing, participants will swish 10 milliliters (mL) of the Experimental Mouthwash vigorously for one minute and then spit it out. No further rinse with water.
Drug: Whitening Toothpaste · Device: Experimental Mouthwash
Participants will brush their teeth using a full ribbon of Regular Fluoride Toothpaste on head of toothbrush provided for two (timed) minutes, twice a day (morning and evening), for approximately 12 Weeks. After each brushing, participants will swish 10 mL of the Experimental Mouthwash vigorously for one minute and then spit it out. No further rinse with water.
Device: Experimental Mouthwash · Drug: Regular Fluoride Toothpaste
Participants will brush their teeth using a Full ribbon of Regular Fluoride Toothpaste on head of toothbrush provided for two (timed) minutes, twice a day (morning and evening), for approximately 12 Weeks.
Drug: Regular Fluoride Toothpaste
A toothpaste containing 5% KNO3 and 0.25% NaF.
A mouthwash containing Dipotassium Oxalate.
A marketed regular fluoride toothpaste containing 0.25% NaF.
Mean Total Modified Lobene Stain Index (MLSI) score [Group 1 Versus (vs.) Group 3]
Extrinsic dental stain will be assessed using the MLSI on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth, and lingual surfaces of the 6 mandibular anterior teeth. Area (A) and intensity (I) of extrinsic dental stain will be scored separately at the four gingival and body sites on the scale 0 to 3, where 0 equal to (=) Area with no stain and no intensity, 1= Area with stain covering up to one third of region and light stain intensity, 2= Area with stain covering up to two thirds of region and moderate stain intensity, 3= Area with stain covering more than two thirds of region and heavy stain intensity. The MLSI score for sites will be calculated by multiplying the Area score by the Intensity score. Thus, the minimum and maximum possible total scores will be 0 and 9 respectively. Lower score indicates an improvement in condition. Mean Total MLSI Score is mean of MLSI score across all evaluable tooth surfaces.
Time frame: At Week 12
Mean Total MLSI score (Group 1 vs. Group 3)
Extrinsic dental stain will be assessed using the MLSI on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth, and lingual surfaces of the 6 mandibular anterior teeth. Area and intensity of extrinsic dental stain will be scored separately at the four gingival and body sites on the scale 0 to 3, where 0= Area with no stain and no intensity, 1= Area with stain covering up to one third of region and light stain intensity, 2= Area with stain covering up to two thirds of region and moderate stain intensity, 3= Area with stain covering more than two thirds of region and heavy stain intensity. The MLSI score for sites will be calculated by multiplying the Area score by the Intensity score. Thus, the minimum and maximum possible total scores will be 0 and 9 respectively. Lower score indicates an improvement in condition. Mean Total MLSI Score is mean of MLSI score across all evaluable tooth surfaces.
Time frame: At Week 6
Mean Total MLSI score (Group 2 vs. Group 3)
Extrinsic dental stain will be assessed using the MLSI on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth, and lingual surfaces of the 6 mandibular anterior teeth. Area and intensity of extrinsic dental stain will be scored separately at the four gingival and body sites on the scale 0 to 3, where 0= Area with no stain and no intensity, 1= Area with stain covering up to one third of region and light stain intensity, 2= Area with stain covering up to two thirds of region and moderate stain intensity, 3= Area with stain covering more than two thirds of region and heavy stain intensity. The MLSI score for sites will be calculated by multiplying the Area score by the Intensity score. Thus, the minimum and maximum possible total scores will be 0 and 9 respectively. Lower score indicates an improvement in condition. Mean Total MLSI Score is mean of MLSI score across all evaluable tooth surfaces.
Time frame: At Week 6 and 12
Mean MLSI score for: Gingival Sites, Body Sites and Interproximal Sites (Group 1 vs. Group 3)
Extrinsic dental stain will be assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth, and lingual surfaces of the 6 mandibular anterior teeth using MLSI. The facial surface of each assessable tooth will be divided into gingival site, body site and interproximal site. Area and Intensity of extrinsic dental stain will be scored separately for each teeth on the scale 0 to 3 and the mean score will be presented, where 0= No stain and no intensity, 1= Stain covering up to one third of region and light stain intensity, 2= Stain covering up to two thirds of region and moderate stain intensity, 3= Stain covering more than two thirds of region and heavy stain intensity. MLSI score= Area score multiplied by Intensity score. Thus, the minimum and maximum possible total scores will be 0 and 9 respectively. Lower score indicates an improvement in condition.
Time frame: At Week 6 and 12
Mean MLSI score for: Gingival Sites, Body Sites and Interproximal Sites (Group 2 vs. Group 3)
Extrinsic dental stain will be assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth, and lingual surfaces of the 6 mandibular anterior teeth using MLSI. The facial surface of each assessable tooth will be divided into gingival site, body site and interproximal site. Area and Intensity of extrinsic dental stain will be scored separately for each teeth on the scale 0 to 3 and the mean score will be presented, where 0= No stain and no intensity, 1= Stain covering up to one third of region and light stain intensity, 2= Stain covering up to two thirds of region and moderate stain intensity, 3= Stain covering more than two thirds of region and heavy stain intensity. MLSI score= Area score multiplied by Intensity score. Thus, the minimum and maximum possible total scores will be 0 and 9 respectively. Lower score indicates an improvement in condition.
Time frame: At Week 6 and 12
Plan to share: Yes — Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trialregister@haleon.com.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2026, 3 months after the start.
Of 52 interventional studies with no phase under Tooth Discoloration, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 18. This study's planned 3 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.