Probiotic Treatment of Orthodontic Patients

Not Applicable

Recruiting

• Conditions: Dental Plaque; Dental Caries

• Registration Number: NCT06751979
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-02
• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-27
• Last Update Submitted: 2024-12-27
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Planimetric plaque quantification	6 weeks	Amount of dental plaque formed after 6 weeks of probiotic treatment

Secondary Outcome Measures

Name	Time	Method
Gingivitis	Immediately after intervention	Gingivitis, as determined by the modified gingival index (MGI) and the sulcus bleeding index (SBI)
Plaque pH	Immediately after intervention	The acidogenic potential of dental plaque, as determined by pH ratiometry
Prevalence of S. salivarius	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

Trial Locations

Locations (1)

Aarhus University, Department of Dentistry and Oral Health; 🇩🇰 Aarhus, Denmark