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 sites6 target enrollmentAugust 4, 2022

Overview

No summary available.

Registry

who.int

Start Date

August 4, 2022

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Melbourne

•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.

•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;