A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste

Completed · Not applicable

Conditions studied: Dentin Sensitivity

In brief

The purpose of this study is to evaluate changes in oral health-related quality of life (OHrQoL) in participants suffering from Dentinal Hypersensitivity (DH) symptoms following the use of anti-sensitivity toothpaste for 24 weeks.

Key facts

Study ID

NCT04964063

Run by

HALEON

People needed

655

Starts

2021-08-31

Expected to finish

2022-05-13

Last updated by the study team

2024-01-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of consent indicating that the participant has been informed of all pertinent aspects of the study.
• The participant must be able to complete all activities as shown in the Schedule of Activities independently on their smart devices.
• Participant who has tooth sensitivity (self-reported symptoms).

You may not qualify if…

• A participant whose sensitivity could be caused by other factors or clinical pathology as established by the screening questionnaire, which also includes:
• A participant who has been/is on multiple prescription medications to treat severe acid reflux on regular basis or considered surgery for acid reflux
• A participant with full or partial denture
• A participant who has undergone treatment within 6 months of screening or is currently under treatment for periodontal or gum disease
• A participant with active periodontitis
• A participant with active caries
• A participant with any chronic and/or severe painful health conditions which lead to regular use pain medications (more than 3 days a week)
• A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients: potassium nitrate (5 percent [%]), sodium fluoride (0.15% weight/volume [w/v] fluoride ion), water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1.

Where it is running

• GSK Investigational Site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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