A Clinical Study to Evaluate the Effectiveness of an Test Toothpaste for the Relief of Dentin Hypersensitivity in a Chinese Population

NCT07352956 | Completed

• 1 other identifier: 300265
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical efficacy of a 0.454 percent (%) weight/weight (w/w) stannous fluoride (SnF2) toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus and tactile stimulus after 28 and 56 days twice daily brushing.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Schiff Sensitivity Score at Day 56

  Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. Change from baseline= Score at Day 56 minus baseline score. A decrease in Schiff sensitivity score indicates an improvement.

  Baseline and Day 56

• Change From Baseline in Tactile Threshold (grams [g]) at Day 56

  The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline. Change from baseline= Score at Day 56 minus baseline score.

  Baseline and Day 56

Secondary Outcomes (5)

• Change From Baseline in Schiff Sensitivity Score at Day 56 (Test versus [vs] Control Toothpaste)

  Baseline and Day 56

• Change From Baseline in Tactile Threshold (g) at Day 56 (Test vs Control Toothpaste)

  Baseline and Day 56

• Change From Baseline in Schiff Sensitivity Score at Day 28

  Baseline and Day 28

• Change From Baseline in Tactile Threshold (g) at Day 28

  Baseline and Day 28

• Change From Baseline in (Visual Analogue Scale) VAS Scores at Day 28 and 56

  Baseline, Day 28 and Day 56

Study Arms (2)

Test Toothpaste

EXPERIMENTAL

Participants will be instructed to brush the two test teeth first, then the whole mouth (all teeth) for at least 1-timed minute, twice daily (morning and evening) for 8 weeks. After brushing, participants will rinse once with 10 milliliter (ml) water using the measuring cup provided.

Drug: Test toothpaste

Control Toothpaste

OTHER

Participants will be instructed to brush the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) for 8 weeks. After brushing, rinse once with 10 ml water using the measuring cup provided.

Drug: Sodium fluoride toothpaste

Interventions

Test toothpaste DRUG

A toothpaste containing 0.454% SnF2.

Test Toothpaste

Sodium fluoride toothpaste DRUG

A regular sodium fluoride toothpaste.

Control Toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent document confirming the participant has been informed of all pertinent aspects of the study and has given their written consent for study participation before any study procedures are performed.
• Participant is biologically male or female.
• Participant is 18 to 70 years of age at the time of signing the consent form.
• Participant is willing and able to comply with the study visit schedule, toothpaste usage instructions, lifestyle restrictions, and other study procedures.
• Participant is in good general, oral, and mental health, which in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history, or upon oral examination that would impact their safety or wellbeing, or the outcomes of the study if they were to participate in the study, or affect their ability to understand and follow study requirements.
• Participant who is willing to receive reminders of appointments and videos reminding them on the brushing instructions.
• Participant must have a self-reported history of tooth sensitivity lasting more than 6 months but not more than 10 years and experience DH symptoms at least 'once a week' or more frequently.
• Participant must be in general oral health, with a minimum of 20 natural teeth.

You may not qualify if:

• Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a sponsor employee directly involved in the conduct of the study or a member of their immediate family.
• Participant who is participating in, or has participated in, other studies (including nonmedicinal studies) involving investigational product(s) within 8 weeks of Screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.
• Participant who is participating in, or has participated in, a study evaluating a tooth desensitizing treatment within 8 weeks of Screening (Visit 1).
• Participant who is using or has used an oral care product indicated for DH relief within 8 weeks of Screening (Visit 1).
• Participant who has had a professional desensitizing treatment within 8 weeks of Screening (Visit 1).
• Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).
• Participant who is unwilling or unable to comply with product usage instructions or Lifestyle Considerations as described in the protocol.
• Participant who habitually rinses with water during toothbrushing (self-reported at Screening (Visit 1), or those observed to rinse with water while brushing during the supervised brushing with the allocated toothpaste at screening (Visit 1) or baseline (Visit 2).
• Female participant who is pregnant or intending to become pregnant during the study (self-reported) or is breastfeeding.
• Participant with a recent history (within the last year) of alcohol and/or substance abuse.
• 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 study 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.
• Participant taking daily doses of medications or traditional herbal treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of pain.
• Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
• Examples of traditional herbal treatments include clove oil, olive oil or other treatments directly applied to the oral cavity for the treatment of oral health conditions.
• Participant taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, may cause xerostomia.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

West China School/Hospital of Stomatology, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

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: January 13, 2026
• First Posted: January 20, 2026
• Study Start: January 16, 2026
• Primary Completion: April 6, 2026
• Study Completion: April 6, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

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

CN (1)