The abilities of different toothpastes to prevent and repair early tooth decay.

Not Applicable

Active, not recruiting

• Conditions: Dental Caries; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Public Health - Other public health

• Registration Number: ACTRN12620000747921
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-21
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

•Aged 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;
•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, chewing gum, and other non-study oral care products during the study;
•Be willing to postpone all elective dental procedures until the study has been completed;
•Be willing to refrain from chewing gums while using the test products;
•Be willing and able to refrain from wearing a nightguard (occlusal splint) for the entire course of the study (for nightguard wearers only).

In addition, to be eligible to participate in this study, an individual will need to 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 at least 1.0 mL/minute and unstimulated whole salivary flow rate at least 0.2 mL/minute.
•Willingness to comply with all study procedures and be available for the duration of the study.
• Only staff and students of the Melbourne Dental School, University of Melbourne will be eligible to participate.

Exclusion Criteria

•Advanced periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
•Active treatment for periodontitis;
•Medical condition which requires premedication prior to dental visits/procedures;
•Untreated dental caries (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 (including sensitivity to dentifrice ingredients) 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 interact with the dentrifice slurries or which 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 well being 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
Percent remineralization of enamel subsurface lesions (the percent change in mineral content values relative to the baseline mineral content). Mineral content will be measured by analysing images of transverse microradiographs of enamel lesions. A microradiography unit will be employed to take the radiographs and a computer program that measures grey values on the radiographs will calculate the mineral content of scans of each lesion. [This outcome will be assessed at the end of each treatment period. As the radiographs will include images of lesions from the same enamel that is attached to the appliances but not exposed to the dentrifice formulations, this outcome measure will not be assessed at the beginning of each treatment period. ]