A Clinical Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity

NCT07802886 | Not Yet Recruiting

• 1 other identifier: 400367
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to demonstrate the clinical efficacy of Test Toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus, compared to a sodium fluoride reference toothpaste, after 8 weeks twice daily use.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Schiff Sensitivity Score at Week 8

  Evaporative (air) sensitivity will be assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0 to 3, where 0 equal to (=) Did not respond to air stimulation; 1= Responded to air stimulus but did not request discontinuation of stimulus; 2= Responded to air stimulus and requested discontinuation or moved from stimulus; 3= Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score will be derived as mean score for the two 'Test Teeth' selected at Baseline by the examiner. Change from Baseline will be calculated by subtracting Baseline score from Week 8 score. Lower score indicates improvement.

  Baseline and Week 8

Secondary Outcomes (3)

• Change from Baseline in Tactile Threshold gram (g) at Week 8

  Baseline and Week 8

• Change from Baseline in Schiff Sensitivity Score at Weeks 2 and 4

  Baseline, Week 2 and Week 4

• Change from Baseline in Tactile Threshold (g) at Weeks 2 and 4

  Baseline, Week 2 and Week 4

Study Arms (2)

Test Toothpaste

EXPERIMENTAL

Participants will dose the toothbrush with a ribbon of Test Toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning \& evening), for approximately 56 days.

Device: Test Toothpaste

Reference Toothpaste (Negative Control)

PLACEBO COMPARATOR

Participants will dose the toothbrush with a ribbon of Reference Toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning \& evening), for approximately 56 days.

Other: Regular Fluoride Toothpaste

Interventions

Test Toothpaste DEVICE

Toothpaste containing 5.0 % weight/weight (w/w) CSPS.

Test Toothpaste

Regular Fluoride Toothpaste OTHER

Regular fluoride toothpaste.

Reference Toothpaste (Negative Control)

Eligibility Criteria

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

You may qualify if:

• Participant provision of signed and dated informed consent before any study procedures are performed.
• Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions, and other study procedures.
• Participant is in good general, oral and mental health with, 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.
• Screening (Visit 1): Participant must have
• History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
• Good general oral health, with a minimum of 20 natural teeth.
• Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all the following criteria:
• Exposed dentine due to facial/cervical erosion, abrasion, or gingival recession (EAR).
• Modified Gingival Index (MGI)= 0 directly adjacent to the exposed dentine (i.e., the test area only).
• Clinical mobility= 0.
• Clinically confirmed DH to both tactile and evaporative (air) stimuli: Qualifying tactile threshold less than or equal to (\<=) 20g and Qualifying Schiff sensitivity score more than or equal to (\>=) 2.
• Baseline (Visit 2, Pre-Treatment)
• Participant must have a minimum of two non-adjacent, accessible teeth (incisors, canines, premolars), in different quadrants, with clinically confirmed DH to both tactile and evaporative (air) stimuli at both Screening (Visit 1) and Baseline (Visit 2).
• Tactile threshold \<= 20g at Screening and Baseline.
• Schiff sensitivity score \>= 2 at Screening and Baseline.

You may not qualify if:

• Participant is an employee of the investigator site directly involved in the conduct of the study, or an employee of the investigator site otherwise supervised by the investigator, or a member of their immediate family.
• Participant is an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
• Female participant who is pregnant or intending to become pregnant during the study (self-reported).
• Female participant who is breastfeeding (self-reported).
• Participant with known or suspected intolerance or hypersensitivity to the study products, any of their stated ingredients or closely related compounds (self-reported).
• Participant with a recent history (within the last year) of alcohol or other substance abuse (self-reported).
• Participant is participating in or has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of Screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.
• Participant has participated in a tooth sensitivity study within 8 weeks of Screening (Visit 1).
• Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used such a product within 8 weeks of Screening (Visit 1).
• Participant takes daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (for example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
• Screening (Visit 1): Participant has taken antibiotics in the 2 weeks prior to Screening (Visit 1).
• Baseline (Visit 2): Participant has taken antibiotics in the 2 weeks prior to Baseline (Visit 2), that is, during the acclimatization period.
• Participant takes daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
• Participant requires antibiotic prophylaxis for dental procedures.
• Participant has had professional tooth de-sensitizing treatment within 8 weeks of Screening (Visit 1).

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

University of Bristol Dental School

Bristol, BS1 2LY, United Kingdom

Location

MeSH Terms

Conditions

Dentin Sensitivity

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-08

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

GB (1)