Clinical trial NCT02677480: The Effect of Probiotic Streptococci and pH-rising Components on the Oral Microbial Flora
Official title: The Effect of Probiotic Streptococci and pH-rising Components on the Oral Microbial Flora in Subjects With Reduced Salivary Secretion Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyposalivation
Keywords: Microflora
Probiotics
Hyposalivation
Lactobacilli
Mutans streptococci
pH-rising components
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vinnova
name: Vastra Gotaland Region
First posted: 2016-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* No open wounds in the oral cavity
* ≥ 10 own teeth
* Experienced dry mouth for at least 1 year
* An unstimulated salivary secretion rate \< 0.1 ml/min
* A stimulated secretion rate \< 0.7 ml/min and high numbers (≥ 10000 cfu/ml) of lactobacilli and/or mutans streptococci on the tongue and/or in dental plaque

Exclusion Criteria:

* Removable prosthesis
* Reduced immune defence
* Serious heart diseases
* Implanted joints or heart valves
* Lactose intolerance (the probiotic streptococci are freeze-dried in skim milk)

Primary outcomes:
measure: Reduction of proportions of mutans streptococci and/or lactobacilli in supragingival plaque and/or on the tongue at 3 months compared with baseline
timeFrame: 3 months
Secondary outcomes:
measure: Reduction of numbers of mutans streptococci and/or lactobacilli in supragingival plaque and/or on the tongue at 3 months compared with baseline
timeFrame: 3 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Institute of odontology
Study officials:
affiliation: Goteborg University
name: Annica Almstahl, Assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References: