Tooth DiscolorationNCT07836998
A Study to Assess the Efficacy of an Experimental Mouthwash Used With a Marketed Whitening Toothpaste on Stain Build-up
A study testing Whitening Toothpaste, Experimental Mouthwash and Regular Fluoride Toothpaste in people with Tooth Discoloration, run by HALEON at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Whitening Toothpaste, Experimental Mouthwash and Regular Fluoride Toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 willing and able to comply with scheduled visits, treatment/application/dosing plan, study restrictions, lifestyle considerations and other study procedures.
- A 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 or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the ability to understand and follow study procedures and requirements.
- At Visit 1 (Screening/Baseline):
- Participant with good oral health.
- Participant with at least 16 natural teeth including the 12 anterior teeth.
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- Participant with all facial surfaces, and mandibular lingual surfaces, of the 12 anterior teeth gradable for the MLSI.
- Participant with presence of extrinsic dental stain (judged to be formed due to ingestion of food or drinks, or use of tobacco products) on the facial surfaces of the anterior teeth, as determined from a gross visual stain assessment.
- Participant with before Prophylaxis (Baseline)- Total MLSI [A multiplied by(x) I] score ((four sites per tooth) of more than equal to (>=) 15 on the facial surfaces of the six maxillary and six mandibular anterior teeth. Note: Total MLSI score (A x I), scored pre-prophylaxis, will be used for stratification, and is derived from the sum of the A x I scores of the facial surfaces of the six maxillary and six mandibular anterior teeth.
Who cannot join
- 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.
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A 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.
- A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
- A participant who is breastfeeding.
- A participant with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients.
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- Participant who is unwilling or, in the opinion of the investigator or medically qualified designee, unable to comply with the requirements and/or lifestyle restrictions of the study.
- Participant with a recent history (within the last year) of alcohol or other substance abuse.
- Participant with Oral soft tissue (OST) examination findings at Screening which, in the opinion of the investigator, could interfere with the conduct of the study (for example, stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling.
- 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:
- Currently daily use of mouthwashes containing ingredients known to cause tooth stain (for example, chlorhexidine or cetylpyridinium chloride).
- Past or current use of minocycline.
- Use of tetracycline or doxycycline within 30 days of Screening and/or during the study
- Daily dose of medications known to cause tooth stain (for example, drugs or supplements containing metal ions known to increase enamel staining).
- Participant who has used any professionally dispensed tooth whitening products 6 months prior to baseline or any over-the-counter tooth whitening products (including e.g., peroxide or blue dye containing toothpaste) 3 months prior to baseline.
- Specific exclusions for assessment teeth:
- Non-vital tooth.
- Tooth with evidence of current or recent carious lesions.
- Tooth used as an abutment for fixed or partial dentures.
- Tooth adjacent to fixed retainers and fixed or removable orthodontic appliances.
- Tooth with surface irregularities, cracked enamel, discoloration due to trauma or orthodontic treatment, tetracycline stain, restorations or hyper/hypoplastic areas, which, in the opinion of the clinical examiner, grading of extrinsic dental stain and tooth shade.
- Tooth with a crown or veneer.
- Tooth with exposed dentine which, in the opinion of the investigator, could impact grading of extrinsic dental stain.
- General oral exclusions:
- Generalized severe gingivitis or advanced periodontal disease; treatment of periodontal disease (including surgery) within 12 months of screening; scaling or root planning within 3 months of screening.
- Any oral condition requiring immediate care.
- Having received a dental prophylaxis within 8 weeks of screening.
- A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
All Sum Research Center LTD
Melbourne, Florida, 32935
Jimmy Qaqish
About this study
Official title: A 12-Week, Randomized, Controlled, Examiner-Blind Clinical Study to Assess the Efficacy of an Experimental Mouthwash Used With a Marketed Whitening Toothpaste on Stain Build-up
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.
Read the detailed description
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).
- Conditions
- Tooth Discoloration
- Being tested
- Whitening Toothpaste, Experimental Mouthwash, Regular Fluoride Toothpaste
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whitening ToothpasteDrug
A toothpaste containing 5% KNO3 and 0.25% NaF.
Experimental MouthwashDevice
A mouthwash containing Dipotassium Oxalate.
Regular Fluoride ToothpasteDrug
A marketed regular fluoride toothpaste containing 0.25% NaF.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Experimental Mouthwash + Marketed Whitening Toothpaste) | Experimental | 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. Receives: Drug: Whitening Toothpaste; Device: Experimental Mouthwash |
| Group 2 (Experimental Mouthwash + Marketed Regular Fluoride Toothpaste) | Experimental | 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. Receives: Device: Experimental Mouthwash; Drug: Regular Fluoride Toothpaste |
| Group 3 (Marketed Regular Fluoride Toothpaste) | Active comparator | 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. Receives: Drug: Regular Fluoride Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 12
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Week 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start25 Sep 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- More trials run by HALEONThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836998
- Sponsor's protocol ID
- 400362
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trialregister@haleon.com.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Controlled, Examiner-Blind Clinical Study to Assess the Efficacy of an Experimental Mouthwash Used With a Marketed Whitening Toothpaste on Stain Build-up
- ClinicalTrials.gov ID
- NCT07836998
- Acronym / sponsor ID
- 400362
- Conditions
- Tooth Discoloration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Experimental Mouthwash + Marketed Whitening Toothpaste) | Experimental | Drug: Whitening Toothpaste, Device: Experimental MouthwashParticipants 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. |
| Group 2 (Experimental Mouthwash + Marketed Regular Fluoride Toothpaste) | Experimental | Device: Experimental Mouthwash, Drug: Regular Fluoride ToothpasteParticipants 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. |
| Group 3 (Marketed Regular Fluoride Toothpaste) | Active comparator | Drug: Regular Fluoride ToothpasteParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 willing and able to comply with scheduled visits, treatment/application/dosing plan, study restrictions, lifestyle considerations and other study procedures.
- A 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 or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the ability to understand and follow study procedures and requirements.
- At Visit 1 (Screening/Baseline):
Key exclusion criteria (28 listed)
- 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.
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A 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.
- A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
- A participant who is breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whitening ToothpasteA toothpaste containing 5% KNO3 and 0.25% NaF. | Drug | Group 1 (Experimental Mouthwash + Marketed Whitening Toothpaste) |
| Experimental MouthwashA mouthwash containing Dipotassium Oxalate. | Device | Group 1 (Experimental Mouthwash + Marketed Whitening Toothpaste), Group 2 (Experimental Mouthwash + Marketed Regular Fluoride Toothpaste) |
| Regular Fluoride ToothpasteA marketed regular fluoride toothpaste containing 0.25% NaF. | Drug | Group 2 (Experimental Mouthwash + Marketed Regular Fluoride Toothpaste), Group 3 (Marketed Regular Fluoride Toothpaste) |
Primary outcome
Mean Total Modified Lobene Stain Index (MLSI) score [Group 1 Versus (vs.) Group 3]
Time frame: At Week 12
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.
4 secondary outcomes
Mean Total MLSI score (Group 1 vs. Group 3)
Time frame: At Week 6
Mean Total MLSI score (Group 2 vs. Group 3)
Time frame: At Week 6 and 12
Mean MLSI score for: Gingival Sites, Body Sites and Interproximal Sites (Group 1 vs. Group 3)
Time frame: At Week 6 and 12
Mean MLSI score for: Gingival Sites, Body Sites and Interproximal Sites (Group 2 vs. Group 3)
Time frame: At Week 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trialregister@haleon.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whitening Toothpaste, Experimental Mouthwash and Regular Fluoride Toothpaste in people with Tooth Discoloration, run by HALEON at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haleon Response Center (+441932 95 95 00, ww.clinical-trial-register@haleon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Total Modified Lobene Stain Index (MLSI) score [Group 1 Versus (vs.) Group 3] (time frame: At Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.