None listed
Conditions
Brief summary
This randomised controlled study will use an assessor-blinded, two-way crossover design to assess the effects of a combination of Tion with 60% CPP-ACP/SnF2 applied under a retainer, and a placebo (no gel) treatment to remineralise/conceal white spots on enamel surfaces using an intra-oral remineralisation model. The Tion gel contains hydrogen peroxide, and the 60% CPP-ACP gel will contain 60% (w/w) CPP-ACP with 1100 ppm fluoride as SnF2. Participants will be randomly allocated to one of the two treatments for each 10 consecutive-day treatment period, during which participants will wear a palatal appliance for 24 hours a day. The participants will rest from the study for one week between each treatment period (washout period). Lay Hypothesis: A combination of a whitening gel TiON and a 60% CPP-ACP/SnF2 gel under a custom retainer can help repair and reduce the appearance of white spots on teeth better than using no treatment (saliva only) control.
Interventions
Aims:
This study aims to test whether applying a special gel containing high levels of milk protein (CPP-ACP) and stannous fluoride can improve or hide white spots on teeth (early signs of decay) more effectively than existing treatments. These white spots can be difficult to treat and often remain visible even after decay is repaired.
Methods & Participants:
healthy adults aged 18–75 will take part in the study voluntarily and will be paid for their time. They’ll first attend a dental check-up,
Aims: This study aims to test whether applying a special gel containing high levels of milk protein (CPP-ACP) and stannous fluoride can improve or hide white spots on teeth (early signs of decay) more effectively than existing treatments. These white spots can be difficult to treat and often remain visible even after decay is repaired. Methods & Participants: healthy adults aged 18–75 will take part in the study voluntarily and will be paid for their time. They’ll first attend a dental check-up, complete a medical questionnaire, and provide saliva samples to confirm eligibility. Each participant will wear a custom-made removable mouth appliance (like a denture) that contains tiny pieces of real tooth enamel with early decay (white spots), prepared in a lab. They will wear this appliance nearly all day and night for two 10-day treatment periods, except while eating, drinking (except water), cleaning their teeth/appliance, or applying products. Treatment A: Participants will receive a whitening treatment (GC TiON) and a special gel containing CPP-ACP and fluoride on the first day. Then, for the next 10 days, they will: Apply the TiON bleach to the enamel slabs before bed. Wear the appliance with the retainer in place for 1 hour. Rinse, then apply the test gel (CPP-ACP/SnF2). Wear the appliance overnight with the gel in place. Treatment B: Participants will wear the appliance for 10 days but will not receive any whitening or gel treatments. The order of treatments will be random, and there will be a one-week break between treatment periods. The dose of CPP-ACP/SnF2 and TiON to be used in each application: Each application will use approximately 0.5 mL of TiON and 0.5 mL of CPP-ACP/SnF2 gel. The 60% CPP-ACP/SnF2 gel will be provided in a plastic syringe for easy injection into the retainer. Participants will be educated on how to apply the bleach and gel. Participants must wear the retainer overnight for a minimum of 8 hours and a maximum of 10 hours. To monitor adherence, participants will record TiON and gel application times, as well as appliance/retainer wear time, in a diary. The completed diary and remaining test products (TiON and gel syringes) must be returned to the research team at the end of the treatment period.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, 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 test agents 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