Actively Recruiting
Effect of the Probiotic Streptococcus salivarius M18 on Dental Biofilm Formation in Orthodontic Patients A Randomized Double-Blind Placebo-Controlled Trial
Led by University of Aarhus · Updated on 2024-12-30
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
B
Bluestone Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how a lozenge containing the probiotic strain Streptococcus salivarius M18 affects the formation, makeup, and harmfulness of dental plaque in healthy orthodontic patients compared to a placebo. The focus is on people undergoing orthodontic treatment with fixed appliances who have a significant amount of plaque. Participants will take a lozenge daily that either contains the probiotic S. salivarius M18 or a placebo. This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the differences in dental biofilm formation and composition between the two groups. Throughout the study, researchers will assess dental plaque using planimetric plaque quantification at 6 weeks. Participants' oral health and plaque levels will be monitored to measure the probiotic's impact on dental biofilm. The study involves healthy individuals aged 10 years or older who have been in orthodontic treatment for over 6 months, with ongoing safety and adherence monitoring.
CONDITIONS
Official Title
Probiotic Treatment of Orthodontic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Generally healthy males and females aged 10 years or older
- Able to read and receive a copy of the signed informed consent form
- Have at least 20 natural teeth
- Undergoing orthodontic treatment with fixed appliances in the upper and/or lower jaw for more than 6 months
- Average plaque score over 2 according to the Modified Orthodontic Plaque Index (MOPI) at screening
You will not qualify if you...
- Significant oral soft tissue disease based on visual examination
- History of allergy or adverse reactions to oral hygiene products or their ingredients
- Allergies to milk proteins
- Allergies to probiotics
- Pregnant or nursing
- Serious medical conditions
- Use of antibiotics or anti-inflammatory medication within 30 days before screening
- Acute sinusitis or severe oral-pharyngeal infections
- Smoking
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aarhus University, Department of Dentistry and Oral Health
Aarhus, Denmark, 8000
Actively Recruiting
Research Team
S
Sebastian Schlafer, DDS
E
Elisabeth Reichardt, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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