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

Not Applicable

• Conditions: Gingivitis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621000885897
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-08
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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.

Exclusion Criteria

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);
11.Current smokers and subjects with a history of alcohol or drug abuse;
12.An existing medical condition (eg: diabetic people) which prohibits eating or drinking for periods up to 4 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified