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A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population | Clinical Trials | Clareo Health

COMPLETEDNA

A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population

A 12-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population

NCT05750745•HALEON

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of the 0.454 percentage (%) weight/weight (w/w) stannous fluoride (SnF2) toothpastes for the relief of dentine hypersensitivity (DH) in China.

Detailed Description

This study will be a single center, randomized, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the 2 selected 'test teeth'), with a treatment period of 12 weeks, to investigate the clinical efficacy of a SnF2 toothpaste for the relief of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialized negative and positive control toothpastes.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any study procedures are performed.
•Participant who is willing and able to understand and comply with scheduled visits, product usage requirements and other study procedures.
•A participant 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 medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
•Participant who owns a smartphone with the WeChat application installed.
•A participant who presents the following oral and dental inclusions will apply at Screening (Visit 1):
•1. Self-reported history of tooth sensitivity lasting more than six months but not more than 10 years and experience DH symptoms at least 'once a week' or more frequently (as mentioned in Screening questionnaire).
•2. Good general oral health, with a minimum of 20 natural teeth.
•3. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH.
•Each eligible tooth must meet all of the following criteria:
•1. Exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR).
+12 more criteria

Exclusion Criteria

•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 has participated in, or has participated in, other studies (including non-medicinal studies) involving investigational product(s) within 30 days of Screening (Visit 1).
•Participant who is participating in, 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 will be required to bring their current oral care products to Visit 1 for staff to verify the absence of known anti-sensitivity ingredients and DH claims.
•Participant who has had a professional de-sensitizing treatment within 8 weeks of Screening (Visit 1).
•Participant who habitually rinses with water during toothbrushing (self-reported at Screening Visit 1).
•Participant who seen to rinse with water while brushing with the acclimatization toothpaste during review of their brushing compliance videos at Baseline (Visit 2).
•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.
•Female participant who is pregnant or intending to become pregnant during the study (self-reported).
+29 more criteria

Locations (1)

Department of Preventive Dentistry, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Key Dates

Start Date

May 8, 2023

Primary Completion Date

September 19, 2023

Completion Date

September 19, 2023

Last Updated

November 20, 2024

Enrollment

416

ACTUAL participants

Conditions

Dentin Sensitivity

Interventions

Sensodyne Sensitivity & Gum

DRUG

Crest Cavity Protection Fresh Lime

DRUG

Sensodyne Repair and Protect

DRUG

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

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Dentin Sensitivity

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COMPLETEDNA

Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity

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Dentin Sensitivity

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COMPLETEDPHASE1/PHASE2

Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population

Inclusion Criteria

Exclusion Criteria

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

Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity

Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients

Efficacy and Safety Assessment of Experimental Bleaching Agents

Propolis in Reducing Dentin Hypersensitivity

A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population