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

NCT02677480 | Completed Phase 1

• 1 other identifier: 662-08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Hyposalivation

Keywords

Microflora; Probiotics; Hyposalivation; Lactobacilli; Mutans streptococci; pH-rising components

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction of numbers of mutans streptococci and/or lactobacilli in supragingival plaque and/or on the tongue at 3 months compared with baseline

  3 months

Study Arms (2)

Test group, probiotic tablets and gel

ACTIVE COMPARATOR

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 COMPARATOR

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

Interventions

Test group, probiotic tablets and gel DIETARY_SUPPLEMENT

Effect of probiotic tablets and gel on acidogenic bacteria

Test group, probiotic tablets and gel

Placebo group, placebo tablets and gel DIETARY_SUPPLEMENT

Effect of placebo tablets and gel on acidogenic bacteria

Placebo group, placebo tablets and gel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead
• Vinnova: collaborator
• Vastra Gotaland Region: collaborator

Study Sites (1)

Institute of odontology

Gothenburg, 41390, Sweden

Location

MeSH Terms

Conditions

Xerostomia

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Annica Almstahl, Assoc. prof.

  Goteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: February 9, 2016
• Study Start: November 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

SE (1)