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 个研究点目标入组 80 人开始时间: 2021年7月8日最近更新: 2021年7月12日

适应症

试验速览

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•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);
•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.

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