A comparison of the effects of two sugar-free chewing gums to 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

• Registration Number: ACTRN12621001416886
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-20
• Last Update Posted: 26 October 2021

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 without a history of allergic or adverse reactions to milk, milk products, tin or tin-containing products;
• 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 times;
• Able to chew gum;
• Be willing to refrain from using non-study dentifrice and mouthrinse during the study period;
• Be willing to postpone all elective dental procedures until the study has been completed;
• 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
• Able to clean their teeth with a manual toothbrush.

Exclusion Criteria

• Advanced gum disease (such as active infection, loose teeth or severely receded
gums);
• Active treatment for advanced gum disease;
• Medical conditions such as those which require premedication prior to dental visits/procedures, chronic disease such as diabetes or use of medications that cause gum swelling chronic diseases;
• Untreated dental decay (cavities);
• History of allergic or other adverse reactions to milk or milk proteins;
• History of allergic or other adverse reactions to ingredients in sugar-free chewing gums such as artificial sweeteners;
• Pregnancy, plans to become pregnant during the study, or lactation;
• Existing dental work which prevents the potential participant wearing the appliance used in the study including orthodontic appliances and removable dentures;
• Treatment with antibiotics or anti-inflammatory medicines in the month prior to starting the study;
• Use of drugs that may interact with the gums tested in this project or which may affect salivary flow rate;
• History of health conditions requiring antibiotic coverage prior to dental treatment;
• Serious infectious disease;
• Any other diseases or conditions that might interfere with examination procedures or the participants safely completing the study;
• Any other medical or dental conditions deemed to put the health and well being of the participant or the research team at risk if the potential participant did participate in the study;
• History of allergic or adverse reactions to toothpaste or toothpaste ingredients;
• History of head and neck radiation treatment (radiotherapy).

Study & Design

• Study Type: Interventional
• Study Design: Not specified