Clinical efficacy of an experimental toothpaste

GlaxoSmithKline Consumer Healthcare (GSKCH)0 sitesNovember 9, 2009

Overview

No summary available.

Registry

who.int

Start Date

November 9, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GlaxoSmithKline Consumer Healthcare (GSKCH)

•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.
•Aged at least 18 years.
•3\.Compliance
•Understands and is willing, able and likely to comply with all study procedures and restrictions.
•4\.General Health
•Good general health in the opinion of the investigator, with no clinically significant and relevant abnormalities of medical history or physical examination.
•5\.Dental Health
•a)A minimum of 20 permanent gradable teeth. A scorable surface is defined as a surface that has 50% of the surface gradable. Third molars, orthodontically banded/ bonded, fully crowned or extensively restored, grossly carious or abutment teeth are not included in the tooth count.
•b)Mild to moderate gingivitis present at the screening visit in the opinion of the investigator.
•c)MGI between 1\.50 and 2\.30 at Pre\-Prophy Baseline and Randomisation visit.

•1\.Pregnancy
•Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
•2\.Breast\-feeding
•Women who are breast–feeding.
•3\.Allergy/Intolerance
•Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
•4\.Dental Health
•a)Have current active caries or periodontitis that may compromise the study or the health of the subjects in the opinion of the investigator or MGI examiner.
•b)Restorations in a poor state of repair.
•c)Partial dentures or orthodontic appliances.