Probiotic Treatment of Orthodontic Patients

NCT06751979 | Recruiting DMC

• 1 other identifier: 1-10-72-77-24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Plaque; Dental Caries

Outcome Measures

Primary Outcomes (1)

• Planimetric plaque quantification

  Amount of dental plaque formed after 6 weeks of probiotic treatment

  6 weeks

Secondary Outcomes (3)

• Prevalence of S. salivarius

  Immediately after intervention

• Gingivitis

  Immediately after intervention

• Plaque pH

  Immediately after intervention

Other Outcomes (1)

• Microbiome composition

  Immediately after intervention

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Dietary Supplement: Probiotic treatment

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotic treatment DIETARY_SUPPLEMENT

Daily intake of a lozenge containing the probiotic strain S. salivarius M18.

Probiotic

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Significant oral soft tissue pathology based on a visual examination.
• 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.
• History of allergies to milk proteins.
• History of allergies towards probiotics.
• Self-reported as pregnant or nursing.
• Self-reported serious medical conditions.
• Antibiotic or anti-inflammatory medication within 30 days of screening visit.
• Acute sinusitis or severe oral-pharyngeal infections.
• Smoker.

Sponsors & Collaborators

• University of Aarhus: lead
• Bluestone Pharma: collaborator

Study Sites (1)

Aarhus University, Department of Dentistry and Oral Health

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Dental Plaque; Dental Caries

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization

Central Study Contacts

Sebastian Schlafer, DDS

CONTACT

42976020; sebastians@dent.au.dk

Elisabeth Reichardt, DDS

CONTACT

17620130691; elisabeth.reichardt@dent.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This clinical trial applies a randomized double-blind placebo-controlled design with two parallel arms.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: October 2, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)