Probiotic Treatment of Orthodontic Patients

Launched by UNIVERSITY OF AARHUS · Dec 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a special lozenge containing a probiotic called S. salivarius M18 can help improve dental health in patients with braces. The study aims to see if this probiotic can change the way dental plaque forms and behaves, which can help prevent cavities. The trial is currently recruiting participants, and it is open to generally healthy individuals aged 10 and older who have at least 20 natural teeth and have been wearing braces for more than six months.

To participate, you'll need to meet certain criteria, like having a plaque score above a specific level during your initial check-up. If you join the trial, you'll receive either the probiotic lozenge or a placebo (a dummy treatment with no active ingredients), and your dental health will be monitored over time. It’s important to note that some people may not be eligible, including those with certain allergies or health conditions. This study could provide valuable insights into how probiotics might help orthodontic patients maintain better oral health!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Generally healthy males and females ≥ 10 years of age.
• • 2. Able to read and receive a copy of the signed informed consent form.
• • 3. Have at least 20 natural teeth.
• • 4. Have been undergoing orthodontic treatment with fixed orthodontic appliances in the upper and/or lower jaw \> 6 months.
• • 5. An average plaque score of \> 2 according to the Modified Orthodontic Plaque Index (MOPI) at the screening appointment.
• Exclusion Criteria:
• • 1. Significant oral soft tissue pathology based on a visual examination.
• • 2. 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.
• • 3. History of allergies to milk proteins.
• • 4. History of allergies towards probiotics.
• • 5. Self-reported as pregnant or nursing.
• • 6. Self-reported serious medical conditions.
• • 7. Antibiotic or anti-inflammatory medication within 30 days of screening visit.
• • 8. Acute sinusitis or severe oral-pharyngeal infections.
• • 9. Smoker.