Real-World Study of a Calcium Sodium Phosphosilicate Anti-Sensitivity Toothpaste for Dentin Hypersensitivity Relief

NCT07300540 | Recruiting

• 1 other identifier: 400303
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the impact of a commercially available desensitizing dentifrice containing 5 percent (%) Calcium sodium phosphosilicate (CSPS) on oral health related quality of life (OHrQoL) in a DH (Dentin Hypersensitivity) population in a real-world setting.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in DHEQ Total Score at Week 24

  The DHEQ is used to measure how DH affects participants quality of life. Section 2 has 34 questions in grouped into 5 domains (Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity). Participants scored each question using a 7-point scale ranging from 1 to 7, where 1= strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score will be derived from the sum of scores across all domains and it ranges from 34 to 238. A lower score indicates a better quality of life regarding DH. Change from Baseline will be calculated by subtracting the Baseline score from the score at Week 24.

  Baseline and Week 24

Secondary Outcomes (20)

• Change From Baseline in DHEQ Restrictions Domain Score at Week 24

  Baseline and Week 24

• Change From Baseline in DHEQ Adaptation Domain Score at Week 24

  Baseline and Week 24

• Change From Baseline in DHEQ Social Impact Domain Score at Week 24

  Baseline and Week 24

• Change From Baseline in DHEQ Emotional Impact Domain Score at Week 24

  Baseline and Week 24

• Change From Baseline in DHEQ Identity Domain Score at Week 24

  Baseline and Week 24

Study Arms (1)

Test Toothpaste

OTHER

Participants will be instructed to brush their teeth twice daily and not more than three times per day using test toothpaste, for 24 weeks.

Other: Calcium sodium phosphosilicate (CSPS) Toothpaste

Interventions

Calcium sodium phosphosilicate (CSPS) Toothpaste OTHER

A toothpaste containing 5% weight/weight (w/w) calcium sodium phosphosilicate.

Test Toothpaste

Eligibility Criteria

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

You may qualify if:

• Participant who has provided consent indicating they have been informed of all pertinent aspects of the study.
• All genders who, at the time of screening, are aged 18 to 65.
• Participant who is able to independently complete all activities on their smart devices
• Participant who has tooth sensitivity (self-reported symptoms).

You may not qualify if:

• Participants whose tooth sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:
• Participant who has been/is on multiple prescription medications to treat severe acid reflux on a regular basis or has had surgery for acid reflux.
• Participant with full or partial denture.
• Participant who has undergone treatment for periodontal or gum disease within 6 months of screening or is currently undergoing treatment for periodontal or gum disease.
• Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
• Participants who have been informed by a DHCP that they have active caries.
• Participant with any chronic and/or severe painful health condition which lead to regular use of pain relief medications (more than 3 days a week).
• Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Citruslabs (Virtual Site)

Las Vegas, Nevada, 89118, United States

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Swathi Varanasi

  Citruslabs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haleon Response Center

CONTACT

+441932959500; ww.clinical-trial-register@haleon.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: March 4, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

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

US (1)