None listed
Conditions
Brief summary
The study is to compare the remineralisation (repair) of early decay-like lesions in tooth treated with sugar free chewing gums containing 0, 5mg and 10mg CPP-ACP (Recaldent) in a randomized, double-blind trial. All participants will wear palatal appliances with attached enamel slabs during each 14 -day treatment period. This study hypothesis is that there is no significant difference between treatments.
Interventions
The objective of this study is to determine the ability of sugar-free gum containing 0, 5mg and 10mg CPP-ACP (Recaldent ®) to remineralize (repair) subsurface enamel lesions in situ.
The sugar free chewing gums containing Recaldent will be provided by Mondelez as coded products in sealed packages and will be stored at room temperature. The code will be held by an independent group and not released until all the data has been acquired. Three randomized treatments (A, B and C) will consist of suga
The objective of this study is to determine the ability of sugar-free gum containing 0, 5mg and 10mg CPP-ACP (Recaldent ®) to remineralize (repair) subsurface enamel lesions in situ. The sugar free chewing gums containing Recaldent will be provided by Mondelez as coded products in sealed packages and will be stored at room temperature. The code will be held by an independent group and not released until all the data has been acquired. Three randomized treatments (A, B and C) will consist of sugar free chewing gums containing 0, 5mg and 10mg Recaldent. A palatal appliance for each participant will be prepared by taking alginate impressions of upper and lower dental arches from which study models will be produced and articulated. For the preparation of the palatal appliance, it will need each participant a single approximately 20 minute visit to the study clinic around three weeks before starting treatment. Removable palatal acrylic appliances covering the first premolars to the last tooth in the arch will be fabricated for each participant. The palatal appliance will consist of a palatal plate that will be retained in the mouth by four stainless steel clasps. Troughs on each side of the palatal appliance adjacent to the palatal surface of maxillary premolar/molar teeth will each accommodate four enamel half-slabs, each containing two demineralized subsurface lesions. Therefore, each appliance will contain four enamel half-slabs. The enamel slabs will be inset into the bilateral troughs of the palatial appliance. The appliances will be designed to ensure their surfaces are smooth and comfortable for the participants. There will be one week washout period before the first treatment. Participants will be instructed to insert their appliances immediately before gum-chewing for 20 min and then retain their appliance in the mouth for another 20 min with their appliances worn 40 min each time. This will be performed four times daily at the following times: 10.00am, 11:30am, 2.00pm and 3:30pm each day for 14 consecutive days including weekends and it will be recorded in participant’s diaries. At all other times, the appliances will be stored in sealed moist plastic bags at room temperature. All participants will cross over to each randomly assigned treatment, with at least one week washout period between treatments. Participants will use standard fluoride dentifrice provided to brush their teeth twice daily (morning and evening) to replace their current toothpaste/teeth-brushing habits for the duration of the clinical study and all washout periods. During a clinical trial period, participants will be instructed not to eat or drink while wearing the appliance and to rinse and clean their appliances using a fluoride-free denture cleanser paste and toothbrush provided. They will be informed not to brush the area containing the enamel blocks. No alterations will be made the participants’ diet and oral hygiene procedures for the duration of the clinical study. After completion of each treatment period, the enamel blocks will be removed from the appliances for processing and measurement of remineralisation of enamel subsurface lesions. The study will be carried out at Melbourne Dental School, University of Melbourne at Royal Dental Hospital of Melbourne.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Outcome results
None listed