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

NCT ID: NCT07300540

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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This will be a decentralized, prospective, 24-week, monadic design, open label, study in a DH population. The study will evaluate changes in OHrQoL in participants with self-reported DH symptoms. OHrQoL will be measured using a validated questionnaire, the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), completed by study participant. Sufficient numbers will be screened to enroll approximately 500 participants to ensure approximately 400 evaluable participants complete the entire study.

Conditions

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Dentin Sensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Test Toothpaste

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

Group Type OTHER

Calcium sodium phosphosilicate (CSPS) Toothpaste

Intervention Type OTHER

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

Interventions

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Calcium sodium phosphosilicate (CSPS) Toothpaste

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* Participants whose tooth sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:

1. 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.
2. Participant with full or partial denture.
3. 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.
4. Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
5. Participants who have been informed by a DHCP that they have active caries.
6. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HALEON

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Swathi Varanasi

Role: PRINCIPAL_INVESTIGATOR

Citruslabs

Central Contacts

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Haleon Response Center

Role: CONTACT

Phone: +441932959500

Email: [email protected]

Other Identifiers

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400303

Identifier Type: -

Identifier Source: org_study_id