The Effect of Probiotic Streptococci and pH-rising Components on the Oral Microbial Flora

Göteborg University

Status and phase: Completed; Phase 1

Conditions: Hyposalivation

Treatments: Dietary Supplement: Test group, probiotic tablets and gel; Dietary Supplement: Placebo group, placebo tablets and gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02677480

662-08

Details and patient eligibility

About

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).

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Test group, probiotic tablets and gel

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Test group, probiotic tablets and gel

Placebo group, placebo tablets and gel

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo group, placebo tablets and gel