None listed
Conditions
Brief summary
This project will compare the repair of early tooth enamel decay after chewing with two sugar-free gums containing the major milk protein casein combined with calcium (called CPP-ACP). One gum will contain CPP-ACP made using an enzyme called trypsin that originates from pigs. The other gum will contain exactly the same ingredients as the first gum including the same amount of CPP-ACP but the CPP-ACP in the second gum will be made using trypsin that originates from a fungus. To test these abilities of these two gums to repair early decay, pieces of pre-sterilized human enamel with artificially-created early decay will be attached to custom-made removable denture-like appliances that will be worn by 10 human participants for 40 minutes four times a day for each of two 10-consecutive weekday treatment periods, and chew gum for the first 20 minutes the appliance is worn each time. A different gum will be chewed during each treatment period. The two treatment periods will be separated by a one-week washout period when the participants will rest from the study while new pieces of enamel are attached to their appliances before they cross-over to the other gum. The order the two gums are chewed will be random and unknown to the participants or researchers.. The hypothesis is that the abilities of the two gums to repair the early decay will be equivalent.
Interventions
This randomized controlled study will use a double-blind, two-way crossover design to assess the effects of chewing two sugar-free gums on the remineralization of artificially-created subsurface enamel lesions (early enamel decay), using an established in situ caries model.
Ten (10) human volunteers will be selected to participate. Potential participants will be given a Plain Language Statement detailing what they will be asked to do and a consent form to sign and date if they agree to particip
This randomized controlled study will use a double-blind, two-way crossover design to assess the effects of chewing two sugar-free gums on the remineralization of artificially-created subsurface enamel lesions (early enamel decay), using an established in situ caries model. Ten (10) human volunteers will be selected to participate. Potential participants will be given a Plain Language Statement detailing what they will be asked to do and a consent form to sign and date if they agree to participate. Each participant will wear a custom-made removable palatal acrylic appliance with four slabs of human enamel attached. The enamel slabs will be pre-sterilized and will contain subsurface lesions created in the laboratory. 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. The appliances will either have been previously fabricated for the participants for previous in situ projects they have participated in or, in the case of participants who have not participated in these projects before, will be newly fabricated for them. One week prior to commencement of the first intervention in this project, a qualified dentist on the research team will ensure the appliance fits correctly and then the enamel slabs will be attached to the appliances by the research team. Participants will wear the appliances four times a day for 40 minutes each time over two 10 consecutive-weekday treatment periods (excluding weekends). There will be two one-week washout periods; one before the first treatment period commences and one between the two treatment periods. During the washout periods participants will not wear their appliance but will brush their teeth only with a standard fluoride toothpaste that they will use throughout the entire project period. During the second washout period, the research team will replace the slabs on the appliances with new pre-sterilized enamel slabs. The two gums will each be randomly allocated to one of the two treatment periods. The two gums will both contain exactly the same ingredients including 1% (by weight) casein, the major protein in milk, combined with calcium (called casein phosphopeptide-amorphous calcium phosphate or CPP-ACP). One gum will contain CPP-ACP manufactured using an enzyme called trypsin/chymotrypsin originating from pigs and the other will contain CPP-ACP made with trypsin/chymotrypsin originating from a fungus. The chewing gums will be supplied in this coded packages by the sponsor of this study. At the start of each treatment period the participants will present to the research department at the Melbourne Dental School to receive their appliances and enough gum to chew over that treatment period. Participants will be randomly allocated to one of the two gums to chew during the first treatment period and cross over to the other gum to chew during the second treatment period. The order the gums are allocated to each participant will be random and unknown to the participants or the researchers analyzing the results. Each participant will complete both 10-day treatment periods and the entire project period will comprise a total of six weeks in total. 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. They will clean their appliance using a toothbrush and fluoride-free toothpaste (both supplied) and then rinse their appliance with distilled de-ionized water (supplied). They will be instructed to avoid brushing and rinsing the enamel slabs and the trough areas surrounding the enamel slabs. When the appliance is not being worn it will be placed in a snap-sealed bag (supplied) with several drops of distilled de-ionized water (supplied) to prevent them drying. During the entire six-week project period they will be instructed to brush their teeth twice a day with a toothbrush and a standard fluoride toothpaste (both supplied) with the appliance out of their mouths during the treatment periods. They will also continue other normal oral hygiene practices throughout the project period. For the duration of the entire project period, participants will be asked to not use any toothpaste other than the standard fluoride toothpaste given to them by the research team, refrain from using any mouthrinses, and will also be instructed not to chew any gum other than chew their allocated gum at the specified times during the treatment periods. Participants will otherwise maintain normal dietary and oral hygiene practices during the project period. Each participant will be requested to inform the research staff if they experience any discomfort wearing the appliance. The qualified dentist on the research team will then assess the problem and adjust the appliance if needed. All participants will be given a diary at the commencement of each treatment period and will be asked to fill in the times they wear the appliance and chew the gum. Participants will also be asked to inform the research team of any adverse events that occur during the treatment periods and note these in the diary. They will return the diary at the conclusion of each treatment period. Participants will be assured they will be free to withdraw from the study at any time without prejudice.
Sponsors
The 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
• Aged 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 without a history of allergic or adverse reactions to milk, milk products, tin or tin-containing products; • 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 times; • Able to chew gum; • Be willing to refrain from using non-study dentifrice and mouthrinse during the study period; • Be willing to postpone all elective dental procedures until the study has been completed; • Be willing and able to refrain from wearing a nightguard (occlusal splint) for the entire course of the study (for nightguard wearers only). In addition, to be eligible to participate in this study, an individual will need to 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 at least 1.0 mL/minute and unstimulated whole salivary flow rate at least 0.2 mL/minute. • Willingness to comply with all study procedures and be available for the duration of the study • Able to clean their teeth with a manual toothbrush.
Exclusion criteria
• Advanced gum disease (such as active infection, loose teeth or severely receded gums); • Active treatment for advanced gum disease; • Medical conditions such as those which require premedication prior to dental visits/procedures, chronic disease such as diabetes or use of medications that cause gum swelling chronic diseases; • Untreated dental decay (cavities); • History of allergic or other adverse reactions to milk or milk proteins; • History of allergic or other adverse reactions to ingredients in sugar-free chewing gums such as artificial sweeteners; • Pregnancy, plans to become pregnant during the study, or lactation; • Existing dental work which prevents the potential participant wearing the appliance used in the study including orthodontic appliances and removable dentures; • Treatment with antibiotics or anti-inflammatory medicines in the month prior to starting the study; • Use of drugs that may interact with the gums tested in this project or which may affect salivary flow rate; • History of health conditions requiring antibiotic coverage prior to dental treatment; • Serious infectious disease; • Any other diseases or conditions that might interfere with examination procedures or the participants safely completing the study; • Any other medical or dental conditions deemed to put the health and well being of the participant or the research team at risk if the potential participant did participate in the study; • History of allergic or adverse reactions to toothpaste or toothpaste ingredients; • History of head and neck radiation treatment (radiotherapy).
Outcome results
None listed