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

Conditions

• Tooth Discoloration

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Whitening Toothpaste — DRUG
  A toothpaste containing 5% KNO3 and 0.25% NaF.
• Experimental Mouthwash — DEVICE
  A mouthwash containing Dipotassium Oxalate.
• Regular Fluoride Toothpaste — DRUG
  A marketed regular fluoride toothpaste containing 0.25% NaF.

Study Details

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.

Key Dates

First listed

Sep 23, 2026

Start date

Sep 30, 2026

Status verified

Sep 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

360 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1 (Experimental Mouthwash + Marketed Whitening Toothpaste)
  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.
• Experimental: Group 2 (Experimental Mouthwash + Marketed 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. 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.
• Active Comparator: Group 3 (Marketed 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.

Primary Outcome Measure

Mean Total Modified Lobene Stain Index (MLSI) score [Group 1 Versus (vs.) Group 3] [ Time Frame: At Week 12 ]

Central Contacts

• Haleon Response Center
  +441932 95 95 00
  [email protected]

Locations (1)

Find similar trials in Melbourne, FL

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