Actively Recruiting
Probiotic Treatment of Orthodontic Patients
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
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
E
Elisabeth Reichardt, DDS
CONTACT
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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