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

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

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).

Study Overview

• Status: Completed
• Conditions: Hyposalivation
• Intervention / Treatment: Dietary supplement: Test group, probiotic tablets and gel; Dietary supplement: Placebo group, placebo tablets and gel

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41390
    • Institute of odontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test group, probiotic tablets and gel; 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; Effect of probiotic tablets and gel on acidogenic bacteria
Placebo Comparator: Placebo group, placebo 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 placebo tablets and gel on acidogenic bacteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Vastra Gotaland Region; Vinnova
• Investigators: Principal Investigator: Annica Almstahl, Assoc. prof., Göteborg University

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Probiotics; Microflora; Mutans streptococci; Lactobacilli; Hyposalivation; pH-rising components
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: 662-08