A Phase 1 interventional study of Test group, probiotic tablets and gel and Placebo group, placebo tablets and gel in Hyposalivation, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-02-09.
Sponsored by Göteborg University · Phase 1, Interventional, and Treatment
The test group consisted of eighteen subjects with hyposalivation used probiotic tablets (≥ 4/day) and gel (once a week) (streptococci, bicarbonate and carbamide) for 3 months and 9 used placebo tablets and gel. The salivary secretion rates were measured and microbial samples collected and analysed using cultivation technique twice both at baseline and at the 3-month follow up (1-2 weeks between the appointments).
The aim was to analyse the effect of daily intake of probiotic alpha-haemolytic facultative anaerobic streptococci (Streptococcus oralis), pH-rising components and Stevia on the oral microflora in hyposalivated subjects.
Material and methods: Subjects with hyposalivation (unstimulated secretion rate of \< 0.1 ml/min and/or a stimulated secretion rate \< 0.7 ml/min) and ≥ 10 000 cfu/ml of mutans streptococci and/or lactobacilli on the tongue or in the supragingival plaque were included. Eighteen subjects used probiotic tablets (≥ 4/day) and gel (once a week) for 3 months and 9 used placebo tablets and gel. The salivary secretion rates were measured and microbial samples collected and analysed using cultivation technique twice both at baseline and at the 3-month follow up (1-2 weeks between the appointments).
254 studies on the registry are indexed under Xerostomia; 47 are open to participants now.
This study's enrollment of 30 is below the median of 42 across 216 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Test group, probiotic tablets and gel: tablets with probiotic bacteria (10exp8/tablet) and pH-rising components and gel (with probiotic bacteria and pH-rising components) in trays on the teeth once a week.
Dietary Supplement: Test group, probiotic tablets and gel
Placebo group, placebo tablets and gel: placebo tablets without probiotic bacteria and pH-rising components and gel (with no probiotic bacteria but with pH-rising components) in trays on the teeth once a week.
Dietary Supplement: Placebo group, placebo tablets and gel
Effect of probiotic tablets and gel on acidogenic bacteria
Effect of placebo tablets and gel on acidogenic bacteria
Reduction of proportions of mutans streptococci and/or lactobacilli in supragingival plaque and/or on the tongue at 3 months compared with baseline
The oral microflora of patients with hyposalivation (unstimulated secretion rate ≤ 0.1 ml/min and/or a stimulated secretion rate ≤ 0.7 ml/min) is analysed. Samples are collected from supragingival plaque and from the tongue and are analysed using cultivation techniques. The total microbial count is registered as well as numbers of streptococci, mutans streptococci and lactobacilli. Patients with counts of mutans streptococci and/or lactobacilli ≥ 10000 colony forming units/ml are randomly included in either the test group or in the placebo group. After 3 months, microbial samples are collected again from supragingival plaque and from the tongue and proportions of microorganisms analysed. Statistically significant differences in proportions of mutans streptococci and lactobacilli between baseline and after 3 months will be analysed using Students' paired t-test.
Time frame: 3 months
Reduction of numbers of mutans streptococci and/or lactobacilli in supragingival plaque and/or on the tongue at 3 months compared with baseline
The oral microflora of patients with hyposalivation (unstimulated secretion rate ≤ 0.1 ml/min and/or a stimulated secretion rate ≤ 0.7 ml/min) is analysed. Samples are collected from supragingival plaque and from the tongue and are analysed using cultivation techniques. The total microbial count is registered as well as numbers of streptococci, mutans streptococci and lactobacilli. Patients with counts of mutans streptococci and/or lactobacilli ≥ 10000 colony forming units/ml are randomly included in either the test group or in the placebo group. After 3 months, microbial samples are collected again from supragingival plaque and from the tongue and the numbers of microorganisms analysed. Statistically significant differences in numbers of mutans streptococci and lactobacilli between baseline and after 3 months will be analysed using Students' paired t-test.
Time frame: 3 months
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Göteborg University