None listed
Conditions
Brief summary
To evaluate the effects of oral care agents on white spots, healthy human participants will wear appliances with tooth enamel slabs containing artificially-created early decay (white spots) attached. During one of the two treatment periods, a gel containing oral care agent will be applied to the surface of enamel slabs on the appliance. For each of the two treatment periods, participants will also be required to apply an oral care tooth crème on the enamel slabs on their appliances three times per day for 14 days. After completion of each treatment, the enamel slab surface colour change and mineral content in the white spots will be analysed. The study hypothesis will be that topical application of oral care agents on white spots will have no effects on colour changes and mineral content change in enamel in situ.
Interventions
Four human participants aged 18 to 75 years of age who fulfil all eligibility criteria will wear custom-made removable denture-like appliances with pre-sterilized slabs of human tooth enamel containing artificially-created early decay (white spots) attached. The appliances will be worn 24 hours a day (except during eating, drinking and oral hygiene) for 14 consecutive days (weekends included) for each of two treatment periods. During one of the two treatment periods, a gel will be applied to the
Four human participants aged 18 to 75 years of age who fulfil all eligibility criteria will wear custom-made removable denture-like appliances with pre-sterilized slabs of human tooth enamel containing artificially-created early decay (white spots) attached. The appliances will be worn 24 hours a day (except during eating, drinking and oral hygiene) for 14 consecutive days (weekends included) for each of two treatment periods. During one of the two treatment periods, a gel will be applied to the surface of each enamel slab on the appliance by the research team on Monday and Friday when participant is required to be present (first and second week of each 14-day treatment period). The anticipated duration of each treatment visit will be up to 35 minutes. This topical procedure to be performed by the research team is comprised of a) 20 sec polishing the enamel slab surface with Prophy paste, b) 20 min treatment of enamel slab surface with 17% Carbamide peroxide (CP), and c) 60% casein phosphopeptide-amorphous calcium phosphate + 1100 ppm F as stannous fluoride (CPP-ACP/SnF2) x2. The gel that contains 60% (w/w) the major milk protein casein combined with calcium (CPP-ACP) and 1100 ppm fluoride as stannous fluoride will be prepared by the research team. For each of the two treatment periods, participants will be required to apply a tooth crème/paste containing 10% CPP-ACP and 900 ppm fluoride as sodium fluoride on the enamel slabs on their appliances three times per day for 14 days. Treatment with topical application of the tooth crème/paste alone on the enamel slabs on the appliance three times a day will be used as a control. At the end of the first treatment period participants will rest from the project for a week (washout period), then will commence another treatment with new pre-sterilized enamel attached to their appliance. The order of the treatments will be random and unknown to the researchers analyzing the data. Once a day participants will also be asked to brush the surface of their appliance that contacts the roof of their mouth and the other surface containing the enamel slabs, but avoiding brushing the slabs and surrounding trough areas housing the enamel slabs using a toothbrush and a fluoride-free toothpaste (both supplied). After brushing their appliance, they will gently rinse both surfaces of their appliance with distilled filtered water using a wash bottle (both supplied) but will be instructed to avoid rinsing the enamel pieces and surrounding trough areas on the appliance. Whenever participants are not wearing their appliance, they will be requested to store it in a sealed plastic bag with a few drops of distilled filtered water (both supplied) at room temperature to keep the appliance and enamel slabs from drying out. Participants will not eat or drink anything (including water) when wearing their appliance but will otherwise continue with their normal dietary habits.
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 Age range: 18 to 75 years. Gender: Males and females. Good general health. At least 22 natural teeth 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. Available for both treatment periods.
Exclusion criteria
The exclusion criteria include: 1) History of adverse or allergic reactions to milk proteins (such as casein), tin or tin-containing products, or any other ingredients in the products; 2) Orthodontic appliances or removable dentures; 3) Veneers, or more than one incisor with an artificial crown; 4) Oral diseases including advanced periodontal disease; 5) Chronic disease such as diabetes or use of medications that cause gum swelling; 6) Untreated decay; 7) Treatment with antibiotics or anti-inflammatory medicines in the month prior to starting the study; 8) Use of drugs that may interact with the toothpaste slurries or which may affect salivary flow rate; 9) History of health conditions requiring antibiotic coverage prior to dental treatment; 10) Pregnancy/lactation; 11) Serious infectious disease; 12) Any other medical or dental condition deemed to put the health and wellbeing of you or the research team at risk if you participated in the study.
Outcome results
None listed