Effect of a Toothpaste containing Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) and Stannous Fluoride on Supragingival Plaque Composition and Gingivitis in Healthy Adults

The University of Melbourne0 个研究点目标入组 40 人开始时间: 2023年8月21日最近更新: 2023年8月28日

适应症

试验速览

暂无简介。

•Inclusion Criteria:
•To be eligible to participate in this study, an individual must meet all of the following criteria:
•1.Ability to understand, and willingness and ability to read and sign, the informed consent form.
•2.Age range: 18 to 75 years old.
•3.Good general health.
•4.Minimum of 20 natural teeth.
•5.A gum-stimulated whole salivary flow rate greater than or equal to 1.0 ml/minute and unstimulated whole salivary flow rate greater than or equal to 0.2 ml/minute.
•6.A baseline mean whole-mouth modified gingival index greater than or equal to 1.5.
•7.A baseline mean whole-mouth plaque index greater than or equal to 1.5.
•8.A baseline mean whole-mouth sulcus bleeding index greater than or equal to 1.0.
•9.Willingness to comply with all study procedures and be available for the duration of the study.

•Exclusion Criteria:
•Individuals who manifest ANY of the following exclusion criteria at the time of randomization will NOT be eligible for the study:
•1.Allergy to milk protein, tin or other ingredients in toothpaste products.
•2.Orthodontic appliances or removable prostheses.
•3.Veneers, or more than one incisor with a prosthetic crown.
•4.Gross oral pathology (including periodontal disease {Community Periodontal Index of Treatment Needs [CPITN] greater than or equal to 3} and tumours of the soft or hard oral tissues).
•5.Chronic disease with concomitant oral manifestations (e.g., diabetes [irrespective of level of control], human immunodeficiency virus infection or acquired immunodeficiency syndrome, use of medications associated with gingival hyperplasia).
•6.Unrestored dentinal caries.
•7.Treatment with antibiotics or anti-inflammatory medication in the month prior to starting the study.
•8.Concomitant pharmacotherapy with drugs that may interact with test drug.
•9.History of conditions requiring antibiotic coverage prior to invasive dental procedures.
•10.Pregnancy/lactation.

发起方