Probiotic Treatment of Orthodontic Patients

Effect of the Probiotic Strain Streptococcus Salivarius M18 on de Novo Formation and Composition of Dental Biofilm in Orthodontic Patients: A Randomized Double-blind Placebo-controlled Clinical Trial.

The purpose of this study is to examine the effect of treatment with a lozenge containing the probiotic strain S. salivarius M18 on the formation, composition and virulence of dental plaque and in healthy orthodontic patients, compared to placebo control.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries; Dental Plaque
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic treatment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian Schlafer, DDS; Phone Number: +45 42976020; Email: sebastians@dent.au.dk
• Study Contact Backup: Name: Elisabeth Reichardt, DDS; Phone Number: +49 17620130691; Email: elisabeth.reichardt@dent.au.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Recruiting
    • Aarhus University, Department of Dentistry and Oral Health
    • Contact: Sebastian Schlafer, Dr.; Phone Number: +45-87167451; Email: sebastians@dent.au.dk
    • Contact: Elisabeth Reichardt, Dr.; Phone Number: 49 17620130691; Email: elisabeth.reichardt@dent.au.dk
    • Sub-Investigator: Elisabeth Reichardt, Dr.
    • Sub-Investigator: Mathilde F Kristensen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Generally healthy males and females ≥ 10 years of age.
2. Able to read and receive a copy of the signed informed consent form.
3. Have at least 20 natural teeth.
4. Have been undergoing orthodontic treatment with fixed orthodontic appliances in the upper and/or lower jaw > 6 months.
5. An average plaque score of > 2 according to the Modified Orthodontic Plaque Index (MOPI) at the screening appointment.

Exclusion Criteria:

1. Significant oral soft tissue pathology based on a visual examination.
2. History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
3. History of allergies to milk proteins.
4. History of allergies towards probiotics.
5. Self-reported as pregnant or nursing.
6. Self-reported serious medical conditions.
7. Antibiotic or anti-inflammatory medication within 30 days of screening visit.
8. Acute sinusitis or severe oral-pharyngeal infections.
9. Smoker.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo
Active Comparator: Probiotic	Dietary supplement: Probiotic treatment; Daily intake of a lozenge containing the probiotic strain S. salivarius M18.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Planimetric plaque quantification	Amount of dental plaque formed after 6 weeks of probiotic treatment	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of S. salivarius	The prevalence and abundance of S. salivarius M18 in saliva, tongue coating and dental plaque samples, as determined by 16S rRNA gene sequencing	Immediately after intervention
Gingivitis	Gingivitis, as determined by the modified gingival index (MGI) and the sulcus bleeding index (SBI)	Immediately after intervention
Plaque pH	The acidogenic potential of dental plaque, as determined by pH ratiometry	Immediately after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome composition	The effects of probiotic treatment on the overall composition of the oral microbiome, assessed by next generation sequencing	Immediately after intervention

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Bluestone Pharma

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 27, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Tooth Demineralization; Dental Plaque; Dental Caries
• Other Study ID Numbers: 1-10-72-77-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No