None listed
Conditions
Brief summary
A chewable tablet MGO (Trademark) 400+ Manuka Honey with Cyclopower (MMHC) is a low GI (Glycaemic Index), sustained-release delivery of a ‘naturally boosted’ high grade New Zealand Manuka honey. It is currently marketed as a ‘tooth-friendly’ dietary supplement, containing methylglyoxal (MGO), xylitol and Cyclopower. While previous research has shown positive effects of Manuka honey on oral health, it is not clear what effects this tablet might have on oral health including mucosal tissues, saliva, periodontal tissues and teeth. Therefore the aims of this study are: 1. To determine if MGO (Trademark) 400+ Manuka Honey with Cyclopower (MMHC) chewable tablets are safe for teeth, soft tissues and gingiva tissues when consumed three times daily for 28 days. 2. To investigate the effect of MGO (Trademark) 400+ Manuka Honey with Cyclopower (MMHC) chewable tablets on dental plaque, periodontal (gum) health, salivary health and bacteria in dental plaque. 3. To compare the effects of MGO (Trademark) 400+ Manuka Honey with Cyclopower chewable tablets with xylitol tablets used three times daily. The outcomes of the study will allow appropriate recommendations with respect to the effect on oral health to be made about this food supplement being used by individuals who may suffer from dry mouth or who wish to use these MGO (Trademark) 400+ Manuka Honey with Cyclopower chewable tablets as a food supplement.
Interventions
Part 1
12 participants will each chew or rinse five times for one minute each time with a one week washout period between each test. For each test product used, the pH of dental plaque will be measured over the next 40 minutes to measure the effect of the test product on the acidity produced in the plaque. They will chew one MGO400+ Manuka Honey tablet (food supplement) with 2.16g honey and 3.93g xylitol; one xylitol tablet with 4g xylitol, 2.5g of Manuka honey, and two rinses with 20ml of
Part 1 12 participants will each chew or rinse five times for one minute each time with a one week washout period between each test. For each test product used, the pH of dental plaque will be measured over the next 40 minutes to measure the effect of the test product on the acidity produced in the plaque. They will chew one MGO400+ Manuka Honey tablet (food supplement) with 2.16g honey and 3.93g xylitol; one xylitol tablet with 4g xylitol, 2.5g of Manuka honey, and two rinses with 20ml of 10% sucrose solution - the standard for determining dental plaque pH. The honey and xylitol test interventions will be compared with the sucrose interventions to determine if they result in the same, more or less acidity in dental plaque. Part 2 15 participants will chew MGO400+ Manuka Honey tablets (food supplement) with 2.16g honey and 3.93g xylitol three times daily for 28 days and 15 participants will chew xylitol tablets with 4g xylitol three times daily for 28 days. The oral health status of each group including the dental plaque pH, the growth of dental plaque, the health of the gingival tissues and the saliva will be recorded at time 0, 14 days, 28 days and then at 56 days to look for any residual effects when compared with baseline and the end of the intervention. At 14 and 28 days, participants will be asked to return unused tablets to allow determination of how reliably the tablets were chewed.
Sponsors
Mandy Suddes PhD, PMP
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. 16-30 years of age 2. Written consent 3. Able to understand and follow instructions 4. Healthy with no conditions impacting on oral health 5. Evidence (including radiographic) of dental caries progression within the last 2 years 6. DMFT >4 (to show caries in more than the occlusal surfaces of the first molars) 7. No antibiotic use in the past 28 days 8. Not allergic to Manuka honey or xylitol
Exclusion criteria
1. Medical condition that impacts on the study 2. Unable to commit for the number of appointments required 3. Dry mouth conditions
Outcome results
None listed