Study to Evaluate the Effectiveness of Test Dentifrice in the Relief of Dentinal Hypersensitivity

NCT07317128 | Completed

• 1 other identifier: RH01748
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the clinical efficacy of test fluoride dentifrice in reducing Dentin Hypersensitivity (DH) with that of a standard fluoride dentifrice, as measured by evaporative air sensitivity after 12 weeks twice daily brushing.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Schiff Sensitivity Score at Week 12 (Test Dentifrice Versus [vs] Negative Control Dentifrice)

  Evaporative (air) sensitivity is evaluated using the Schiff Sensitivity Score on test teeth for each participant. After the examiner applies a standardized air stimulus, the participant's response is rated on a 0 to 3 scale, where 0= no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus. The lower score indicates improvement. Change from baseline will be calculated by subtracting the baseline score from the score at Week 12.

  Baseline and Week 12

Secondary Outcomes (9)

• Change from Baseline in Schiff Sensitivity Score at Weeks 2, 4 and 8 (Test Dentifrice vs Negative Control Dentifrice)

  Baseline, Weeks 2, 4, and 8

• Mean Change from Baseline in Visual Analogue Scale (VAS) at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)

  Baseline, Weeks 2, 4, 8 and 12

• Mean Change from Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)

  Baseline, Weeks 2, 4, 8 and 12

• Mean Change from Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)

  Baseline, Weeks 2, 4, 8 and 12

• Mean Change from Baseline in VAS at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)

  Baseline, Weeks 2, 4, 8 and 12

Study Arms (3)

Test Dentifrice

EXPERIMENTAL

Participants will be instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.

Drug: Test Dentifrice

Comparator Dentifrice

ACTIVE COMPARATOR

Participants will be instructed to apply a full ribbon of the comparator dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.

Drug: Colgate Sensitive ProRelief

Negative Control Dentifrice

ACTIVE COMPARATOR

Participants will be instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.

Drug: Colgate Triple Protection

Interventions

Test Dentifrice DRUG

Dentifrice containing 1450 parts per million (ppm) fluoride as sodium monofluorophosphate.

Test Dentifrice

Colgate Sensitive ProRelief DRUG

A marketed dentifrice.

Comparator Dentifrice

Colgate Triple Protection DRUG

A marketed dentifrice.

Negative Control Dentifrice

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant demonstrates understanding of the study and is willing to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Participant is 18 to 60 years of age.
• Participant understands and is willing, able and likely to comply all study procedures and restrictions.
• Participant with good general and mental health, in the opinion of the investigator or medically qualified designee:
• No clinically significant and relevant abnormalities of medical history or physical /oral examination.
• Absence of any condition that would impact on the participant's safety or wellbeing or affect the participant's ability to understand and follow study procedures and requirements.
• Self-reported history of DH lasting more than 6 months but not more than 10 years and minimum of 20 natural teeth.

You may not qualify if:

• Female participant who is known to be pregnant or who is intending to become pregnant over the duration of the study.
• Female participant who is breast-feeding.
• Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Participation is in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit.
• Participant who has had tooth desensitizing treatment within 8 weeks of Screening visit (professional sensitivity treatments and non-dentifrice sensitivity treatments).
• Participant who had previously participated in this study.
• Participant with a recent history (within the last year) of alcohol or other substance abuse.
• Participant who is an employee of the sponsor or the study site or members of their immediate family.
• Participant with presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
• Participant with any condition or daily doses of a medication which, in the opinion of the investigator, is causing xerostomia.
• Participant with dental prophylaxis within 4 weeks of screening.
• Participant with tongue or lip piercing or presence of dental implants.
• Participant with gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening.
• Participant who did teeth bleaching within 8 weeks of screening.
• Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

School and Hospital of Stomatology, Wuhan University

Wuhan, Hubei, 430079, China

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Minquan Du, DSS, PhD

  Wuhan University

  PRINCIPAL INVESTIGATOR

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: December 19, 2025
• First Posted: January 5, 2026
• Study Start: January 20, 2013
• Primary Completion: June 8, 2013
• Study Completion: June 8, 2013
• Last Updated: January 5, 2026

Record last verified: 2025-12

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)