Probiotic Treatment of Orthodontic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic treatment, Placebo.
- Who it may be relevant to
- Registry conditions: Dental Plaque, Dental Caries. Basic parameters: from 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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.
Overview
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.
Interventions
- Dietary supplement Probiotic treatment
Daily intake of a lozenge containing the probiotic strain S. salivarius M18. - Dietary supplement Placebo
Placebo
Primary outcome measures
- Planimetric plaque quantification [Time frame: 6 weeks]
Secondary outcome measures (3)
- Prevalence of S. salivarius [Time frame: Immediately after intervention]
- Gingivitis [Time frame: Immediately after intervention]
- Plaque pH [Time frame: Immediately after intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Aarhus University, Department of Dentistry and Oral Health — Aarhus
Identifiers
NCT: NCT06751979 · 1-10-72-77-24