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NCT Number: NCT06751979

Probiotic Treatment of Orthodontic Patients

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.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University, Department of Dentistry and Oral Health

Aarhus, 8000, Denmark

Location status: Recruiting

Location contact

Elisabeth Reichardt, Dr.

CONTACT

[email protected]

17620130691 ext. 49

Elisabeth Reichardt, Dr.

SUB_INVESTIGATOR

Mathilde F Kristensen, PhD

SUB_INVESTIGATOR

Sebastian Schlafer, Dr.

CONTACT

[email protected]

+45-87167451

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Probiotic treatment

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Planimetric plaque quantification

    Time frame: 6 weeks

    Amount of dental plaque formed after 6 weeks of probiotic treatment

Secondary outcomes

  1. Prevalence of S. salivarius

    Time frame: Immediately after intervention

    The prevalence and abundance of S. salivarius M18 in saliva, tongue coating and dental plaque samples, as determined by 16S rRNA gene sequencing

  2. Gingivitis

    Time frame: Immediately after intervention

    Gingivitis, as determined by the modified gingival index (MGI) and the sulcus bleeding index (SBI)

  3. Plaque pH

    Time frame: Immediately after intervention

    The acidogenic potential of dental plaque, as determined by pH ratiometry

Other outcomes

  1. Microbiome composition

    Time frame: Immediately after intervention

    The effects of probiotic treatment on the overall composition of the oral microbiome, assessed by next generation sequencing

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth Reichardt, DDS

CONTACT

[email protected]

17620130691 ext. +49

Sebastian Schlafer, DDS

CONTACT

[email protected]

42976020 ext. +45

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Bluestone Pharma

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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