None listed
Conditions
Brief summary
There is evidence that casein, a major protein in milk, combined with calcium and phosphate, called CPP-ACP may inhibit growth of dental plaque, alter the bacterial composition of plaque and inhibit development of gum inflammation. A large clinical study has been proposed, which will measure the effects of chewing gum containing CPP-ACP on dental plaque growth, plaque bacterial composition and gum inflammation. In order to determine whether this study is feasible, a smaller scale study (pilot study) is required to be conducted. The aims of this pilot study are to compare re-growth of dental plaque, changes in bacterial composition of plaque, and development of gum inflammation after: 1) chewing with sugar-free gum containing added CPP-ACP; 2) chewing with sugar-free gum without added CPP-ACP; 3) no gum chewing at all, each for 14 days each in the absence of all oral hygiene practices. Eighteen adult participants will be recruited from staff and students of the Melbourne Dental Schools and their friends and family. Potential participants will first be screened by filling out a health questionnaire, having a dental examination by a qualified dentist on the research team, and providing two saliva samples; one at rest and one while chewing sugar-free gum, for two minutes each to ensure they produce normal amounts of saliva. These procedures will ensure participants will have no medical or dental conditions that might put them at risk by participating in this study. The order of the three treatments will be random for each participant and unknown to researchers analysing the results. If they are chewing one of the gums, they will chew two pellets of their allocated six times a day for 20 minutes each time and abstain from all oral hygiene practices and not chew any other gum for the 14 days. If they are not chewing gum they will just abstain from all oral hygiene practices and not chew any other gum for the 14 days. The identity of the gums will be unknown to the participants. At the start and end of each treatment period, participants will have a dental examination by the dentist on the research team to measure plaque (by staining their teeth with a plaque disclosing dye) and measure the amount of gum inflammation by visual inspection. They will also have plaque above the gums collected from all their posterior teeth, which will be pooled together and analysed later for bacterial composition. They will then have all their teeth cleaned by the dentist, At the end of the study they will also have a professional fluoride treatment. Participants will be instructed to contact the research team if they experience any problems during the study so that a qualified dentist on the team can assess and deal with the problem accordingly. Participants will be paid for their time and commitment to the study and will be free to exit the study at any time.
Interventions
Participants will be asked to chew one slab of two different sugar-free gums for 20 minutes, six times a day for 14 days each or not chew gum at all for 14 days. Each participant will complete each treatment and the order of treatments will be random. One gum will contain 56.4 mg of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) per one slab or two pellets of gum, The other gum will contain the same ingredients except it won't contain any CPP-ACP. During each 14-day treatment pe
Participants will be asked to chew one slab of two different sugar-free gums for 20 minutes, six times a day for 14 days each or not chew gum at all for 14 days. Each participant will complete each treatment and the order of treatments will be random. One gum will contain 56.4 mg of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) per one slab or two pellets of gum, The other gum will contain the same ingredients except it won't contain any CPP-ACP. During each 14-day treatment period, participants will abstain from all oral hygiene procedures (tooth brushing, use of interdental sticks, flossing, mouthwashes and any other oral hygiene aids) .There will be a 14-day rest period between each treatment period when they will resume oral hygiene procedures. At the beginning and end of each treatment period, participants will have their gums examined to score the level of gingivitis and will also have supragingival plaque levels measured using a plaque-disclosing dye. They will then have all supragingival plaque removed from each posterior tooth, which will be pooled and later analysed for microbial composition. They will then have all supragingival plaque removed from all remaining teeth (professional scale and clean). At the end of the study they will also have a professional fluoride treatment . All dental examinations, plaque sampling, tooth cleaning and fluoride treatments will be conducted by a qualified dentist on the research team. Participants will return all used and unused gum wrappers at the end of each treatment period.
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Good general health. 2. Minimum of 20 natural teeth. 3. A gum-stimulated whole salivary flow rate 1.0 ml/minute and an unstimulated whole salivary flow rate of 0.2 ml/minute. 4. Available for each treatment period.
Exclusion criteria
1. Allergy to milk protein or other ingredients in the gum product 2. Orthodontic appliances or removable prostheses. 3. Veneers, or more than one incisor with a prosthetic crown. 4. Gross oral pathology (including periodontal disease (CPITN score greater than or equal to 3) and tumours of the soft or hard oral tissues). 5. Unrestored dentinal caries 6. Treatment with antibiotics or anti-inflammatory medication in the month prior to starting the study. 7. History of conditions requiring antibiotic coverage prior to invasive dental procedures. 8. Pregnancy/lactation.
Outcome results
None listed