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

Hyposalivation Clinical Trial

Official title:

The Effect of Probiotic Streptococci and pH-rising Components on the Oral Microbial Flora in Subjects With Reduced Salivary Secretion Rate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677480
• Other study ID #: 662-08
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2015
• Last updated: February 4, 2016
• Start date: November 2010
• Est. completion date: November 2010

Study information

• Verified date: February 2016
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyposalivation

Intervention

Dietary Supplement:
• Test group, probiotic tablets and gel
Effect of probiotic tablets and gel on acidogenic bacteria
• Placebo group, placebo tablets and gel
Effect of placebo tablets and gel on acidogenic bacteria

Locations

Country	Name	City	State
Sweden	Institute of odontology	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region, Vinnova

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No
Secondary	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.	3 months	No