Evaluation of the ability of sugar free chewing gum containing 5mg and 10mg casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) to remineralize enamel subsurface lesions in a human in situ model

niversity of Melbourne0 个研究点目标入组 6 人开始时间: 2022年8月4日最近更新: 2022年8月15日

适应症

试验速览

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•Inclusion Criteria
•To be included in the study, each participant must:
•Be 18-75 years of age;
•Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
•Be in good general health based on medical/dental history and oral exam;
•Have no history of adverse or allergic reactions to milk or casein-containing products (such as casein phosphopeptides);
•Agree not to participate in any other oral study for the study duration;
•Have a reasonable functional dentition as determined by the oral examiner and sufficient teeth to support the fabricated dental appliance;
•Be willing to participate in the study, able to follow the study directions, successfully tolerate/perform all study procedures, and willing to return for all specified visits at their appointed time;
•Be willing to refrain from using non-study dentifrice, mouth rinse, and other non-study chewing gums and other oral care products during the study.
•In addition, to be eligible to participate in this study, an individual must also meet ALL the following criteria:
•Ability to understand, and ability to read and sign, the informed consent form;
•Have at least 22 natural teeth;
•Have a gum-stimulated whole salivary flow rate > 1.0 ml/minute and unstimulated whole salivary flow rate > 0.2 ml/minute.
•Willingness to comply with all study procedures and be available for the duration of the study.

•Exclusion Criteria
•Participants are excluded from study participation where there is evidence of:
•Advanced periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
•Active treatment for periodontitis;
•A medical condition which requires premedication prior to dental visits/procedures;
•Untreated dental problems (e.g. cavities);
•Self-reported pregnancy or plans to become pregnant during the study;
•Existing dental work which prevents wearing of the appliance including orthodontic appliances or removable dentures;
•Chronic disease such as diabetes or use of medications that cause gum swelling;
•Any diseases or conditions that might interfere with examination procedures or the participant safely completing the study;
•Treatment with antibiotics or anti-inflammatory medicines in the month prior to starting the study;
•Use of drugs that may affect salivary flow rate;
•History of health conditions requiring antibiotic coverage prior to dental treatment;
•Serious infectious disease;
•Any other medical or dental conditions deemed to put the health and wellbeing of the participant or research team at risk if the potential participant participated in the study.

发起方

niversity of Melbourne