Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice

Conditions

• Dentin Hypersensitivity

Eligibility Criteria

Sex

ALL

Age

12 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Stannous fluoride and Potassium nitrate Dentifrice — DRUG
  Fluoride dentifrice
• Stannous fluoride Dentifrice — DRUG
  Fluoride dentifrice
• Potassium nitrate Dentifrice — DRUG
  Non-fluoride dentifrice
• Vehicle Dentifrice — DRUG
  Placebo dentifrice

Study Details

The aim of this clinical study is to demonstrate the superior antihypersensitivity efficacy of a novel stannous fluoride (SnF2) and potassium nitrate (KNO3) dentifrice (Investigational Product), compared to SnF2 only, KNO3 only and Vehicle dentifrices, after 8 weeks twice daily use.

Key Dates

Start date

Sep 16, 2025

Status verified

Feb 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

850 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Test Dentifrice
  Participants will be instructed to dose the toothbrush head with the Test Dentifrice (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth.
• Active Comparator: Reference Dentifrice 1
  Participants will be instructed to dose the toothbrush head with Reference Dentifrice 1 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth.
• Active Comparator: Reference Dentifrice 2
  Participants will be instructed to dose the toothbrush head with Reference Dentifrice 2 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth.
• Placebo Comparator: Reference Dentifrice 3
  Participants will be instructed to dose the toothbrush head with Reference Dentifrice 3 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth.

Primary Outcome Measure

Change from Baseline in Schiff sensitivity score at Week 8 (Test Dentifrice Versus [Vs] Reference Dentifrices 1, 2 and 3) [ Time Frame: Baseline and Week 8 ]

Central Contacts

• Haleon Response Center
  +441932959500
  [email protected]

Locations (3)

Find similar trials in Melbourne, FL

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