None listed
Conditions
Brief summary
The study is to compare the remineralisation (repair) of early decay-like lesions in tooth after rinsing with two tooth crème/paste slurries prepared containing: (i) a major milk protein casein, combined with calcium and phosphate (CPP-ACP) and stannous (tin) fluoride (Treatment A); (ii) stannous fluoride alone (Treatment B) in a randomized, double-blind trial. All participants will wear palatal appliances for 14 consecutive days in each of the two treatment periods. This study hypothesis is that treatment A that contains 1% of CPP-ACP with 220ppm fluoride as stannous (tin) fluoride, will enhance remineralisation compared to Treatment B containing 220ppm fluoride as stannous (tin) fluoride alone.
Interventions
This study will investigate the remineralisation (repair) of early decay-like lesions in tooth enamel after rinsing with two tooth crème/paste slurries prepared by diluting, in distilled filtered (DF) water, tooth crème/pastes containing: (i) a major milk protein casein, combined with calcium and phosphate called CPP-ACP and stannous (tin) fluoride; (ii) stannous fluoride alone. Each treatment will consist of a 1 min rinse with 5 ml of suspension (1g of product suspended in 4 ml Milli Q water) f
This study will investigate the remineralisation (repair) of early decay-like lesions in tooth enamel after rinsing with two tooth crème/paste slurries prepared by diluting, in distilled filtered (DF) water, tooth crème/pastes containing: (i) a major milk protein casein, combined with calcium and phosphate called CPP-ACP and stannous (tin) fluoride; (ii) stannous fluoride alone. Each treatment will consist of a 1 min rinse with 5 ml of suspension (1g of product suspended in 4 ml Milli Q water) four times a day for 14 consecutive days. One treatment will be a tooth creme/paste slurries containing 1% of CPP-ACP, 220ppm microgram per milliliter of stannous fluoride; and another treatment will be a tooth crème/paste slurries containing 220ppm microgram per milliliter of stannous fluoride alone as control. The Results of this study may provide valuable data assisting further development of a treatment based on CPP-ACP with stannous fluoride that can effectively promote remineralisation (repair) early decay-like lesions in tooth enamel and dentine. This in situ clinical study will use a randomized, double-blind, crossover design to assess the effects after rinsing with two tooth crème/paste slurries on promoting enamel and dentine remineralization using an intra-oral remineralization model. Participants will wear a custom-made removable palatal acrylic appliance for 14 consecutive days in each of the two treatment periods. The appliances will be fabricated for the participants under the direct supervision of a registered prosthetist/dental technician at the Royal Dental Hospital of Melbourne. Palatal appliances will contain four presterilized enamel and dentine slabs with demineralised lesions. Participants will wear the appliance for 40 minutes four times a day for two 14-day treatment periods. Participants will be required to rinse with the slurry at the following times: 9.30 am, 11.00 am, 1.30 pm and 3.30 pm, and to keep a record of the time in the diary provided for appliance worn. During the treatment periods, participants will not eat or drink anything when wearing their appliance and will not wear their appliance when participating in sporting activities. The entire project period will comprise a total of five weeks including one-week washout periods between treatments. During the entire five-week project period they will be instructed to brush their teeth twice a day (i.e. start of the day and end of the day) with a toothbrush and a standard fluoride toothpaste (both supplied) with the appliance out of their mouths during the treatment periods. 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
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
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