Clinical research study to evaluate the effect on gingival inflammation of a toothpaste containing vitamin D in patients with established dental plaque and gingivitis.

The University of Queensland0 sites80 target enrollmentJuly 8, 2021

Overview

No summary available.

Registry

who.int

Start Date

July 8, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\.Males and females, between 18\-70 years of age;
•2\.Availability for the duration of the study;
•3\.Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
•4\.Willingness to provide information related to their medical history;
•5\.Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns);
•6\.Initial gingivitis index average score of 1\.5 as determined by the use of the Loe and Silness Gingival Index, more than 30% of bleeding sites and absence of periodontal disease;
•7\.Informed Consent Form signed.

•1\.Subjects with Pocket Depth \> 4 mm and those presenting purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone;
•2\.Oral pathology or a history of allergy to testing products;
•3\.Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti\-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
•4\.Subject participating in any other clinical study;
•5\.Subject pregnant or breastfeeding;
•6\.Subject who has co\-habitants participating this current clinical trial;
•7\.Subject allergic to oral care products, personal care consumer products, or their ingredients;
•8\. Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;
•9\.Subjects taking Vitamin D supplements 3 months prior to the start of the study;
•10\.Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);