A clinical study investigating the efficacy of an occluding dentifrice in providing relief from dentinal hypersensitivity

GlaxoSmithKline Consumer Healthcare0 sites240 target enrollmentApril 25, 2016

Overview

Registry

who.int

Start Date

April 25, 2016

End Date

June 30, 2016

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

GlaxoSmithKline Consumer Healthcare

•1\. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
•2\. Aged 18\-65 years.
•3\. Good general and mental health with, in the opinion of the investigator or medically qualified designee:
•3\.1\. No clinically significant and relevant abnormalities of medical history or oral examination.
•3\.2\. Absence of any condition that would impact on the subject’s safety or well\-being or affect the individual’s ability to understand and follow study procedures and requirements.
•4\. Understands and is willing, able and likely to comply with all study procedures and restrictions.
•5\. Dental health:
•At Visit 1 (Screening):
•5\.1\. Self\-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
•5\.2\. Minimum of 20 natural teeth.

•1\. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
•2\. Women who are breast\-feeding
•3\. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
•4\. Clinical study/experimental product:
•4\.1\. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
•4\.2\. Previous participation in this study
•5\. Recent history (within the last year) of alcohol or other substance abuse
•6\. An employee of the sponsor or the study site or members of their immediate family
•The site for this protocol is the Clinical trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials unit are eligible to participate
•7\. Disease