A Study to Assess the Efficacy of an Experimental Mouthwash Used With a Marketed Whitening Toothpaste on Stain Build-up

NCT07836998 | Not Yet Recruiting FDA Device

• 1 other identifier: 400362
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Discoloration

Outcome Measures

Primary Outcomes (1)

• 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.

  At Week 12

Secondary Outcomes (4)

• Mean Total MLSI score (Group 1 vs. Group 3)

  At Week 6

• Mean Total MLSI score (Group 2 vs. Group 3)

  At Week 6 and 12

• Mean MLSI score for: Gingival Sites, Body Sites and Interproximal Sites (Group 1 vs. Group 3)

  At Week 6 and 12

• Mean MLSI score for: Gingival Sites, Body Sites and Interproximal Sites (Group 2 vs. Group 3)

  At Week 6 and 12

Study Arms (3)

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.

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.

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.

Drug: Regular Fluoride Toothpaste

Interventions

Whitening Toothpaste DRUG

A toothpaste containing 5% KNO3 and 0.25% NaF.

Group 1 (Experimental Mouthwash + Marketed Whitening Toothpaste)

Regular Fluoride Toothpaste DRUG

A marketed regular fluoride toothpaste containing 0.25% NaF.

Group 2 (Experimental Mouthwash + Marketed Regular Fluoride Toothpaste); Group 3 (Marketed Regular Fluoride Toothpaste)

Experimental Mouthwash DEVICE

A mouthwash containing Dipotassium Oxalate.

Group 1 (Experimental Mouthwash + Marketed Whitening Toothpaste); Group 2 (Experimental Mouthwash + Marketed Regular Fluoride Toothpaste)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

All Sum Research Center LTD

Melbourne, Florida, 32935, United States

Location

MeSH Terms

Conditions

Tooth Discoloration

Interventions

hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Haleon Response Center

CONTACT

+441932 95 95 00; ww.clinical-trial-register@haleon.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)