None listed
Conditions
Brief summary
This research project aims to evaluate whether the microbial ecology of dental plaque biofilms can be altered by toothpastes containing Casein Phosphopetide-Amorphous Calcium Phosphate (CPP-ACP). Two CPP-ACP toothpastes will be assessed in this study: (1) a CPP-ACP toothpaste (commercial name MI Paste® ONE) containing 1100 ppm fluoride; and (2) an 'All-in-one' CPP-ACP toothpaste that contains natural organic cranberry extracts in addition to the CPP-ACP and 1100 ppm fluoride. A double-blinded clinical trial will be used to compare the two CPP-ACP toothpastes with each other and with a active control toothpaste containing the standard 1100 ppm fluoride, but no CPP-ACP or cranberry extract. Oral plaque swab samples will be collected at baseline and at end of four week trial period from study participants. The plaque samples will undergo microbial analysis to evaluate whether there any changes in the numbers of disease-causing or health-associated oral microflora, before and after using the trial toothpastes.
Interventions
Two test toothpastes are being trialed : (1) a CPP-ACP toothpaste with 1100 ppm fluoride, & (2) a CPP-ACP - Cranberry extract toothpaste with 1100 ppm fluoride. These two trial toothpastes will be compared with each other and with an active toothpaste that contains the standard 1100 ppm fluoride concentration, but no CPP-ACP or cranberry extract.
It is proposed that potential study participants will brush twice-daily with a pea-sized amount of one of the toothpastes as part of routine oral hygi
Two test toothpastes are being trialed : (1) a CPP-ACP toothpaste with 1100 ppm fluoride, & (2) a CPP-ACP - Cranberry extract toothpaste with 1100 ppm fluoride. These two trial toothpastes will be compared with each other and with an active toothpaste that contains the standard 1100 ppm fluoride concentration, but no CPP-ACP or cranberry extract. It is proposed that potential study participants will brush twice-daily with a pea-sized amount of one of the toothpastes as part of routine oral hygiene measures for the four weeks of the clinical trial. Which toothpaste a participant will use will be determined by a randomised blinded allocation after the study participants are recruited. Adherence to the intervention will be monitored by weighing the toothpastes tubes at the beginning and end of the trial to estimate the extent of compliance of the study participants in using the trial toothpastes. As with all CPP-ACP oral care products currently available in the market, the concentration of CPP-ACP in the trial toothpastes will be 10% (w/v). Highly-purified organic cranberry extracts will be added to the CPP-ACP-Cranberry toothpaste at a concentration of 250-500µg/mL.
Sponsors
Prof. Laurence Walsh
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
(1)Undergoing fixed orthodontic treatment in both arches, with treatment having been underway for at least 1 month, (2) A minimum of 10 years of age and at least 4 fully erupted permanent maxillary anterior teeth. (3) Good general physical health as determined by a review of the medical history, (4) Available to attend a review appointment in 4 weeks, and (5) Not currently using antibiotics or any antibacterial/anti-plaque mouth rinses.
Exclusion criteria
(1) Any medical condition or disability preventing normal manual tooth brushing, (2) Allergy to milk casein proteins or intolerance to any of the components of the CPP-ACP toothpastes, (3) Unwillingness to use a fluoridated dentifrice, (4) Untreated periodontal disease, (5) Clinical evidence of active caries.
Outcome results
None listed