Evaluation of the effects of sugar free chewing gums containing oral care agent on early tooth decay.

Not Applicable

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

• Registration Number: ACTRN12622001081707
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-04
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remineralisation of artificially-created enamel subsurface carious lesions measured by calculating the difference in mineral content of lesions exposed to the chewing gums containing 0, 5mg and 10mg Recaldent, using microdensitometric analysis of microradiographic images of the lesions.[14 days post-intervention commencement.]