NCT06752330

Evaluation of the Effect of a Probiotic in Patients Undergoing Orthodontic Therapy

Evaluation of the Effect of a Probiotic in Subjects Undergoing Fixed Orthodontic Appliances With Multibrackets or Clear Aligners: a Single-blind Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 10 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

Orthodontic patients need supplementary oral hygiene tools in addition to professional oral hygiene. The aim of this study is to evaluate the effects of Bifidobacterium animalis subs. Lactis HN019 on plaque accumulation and gingival bleeding in orthodontic patients.

Conditions

• Orthodontics
• Dental Hygiene
• Gingivitis and Periodontal Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Use of probiotics during oral hygiene at home	The probiotic used in the study is Bifidobacterium Lactis HN019, distributed com-mercially in Italy by Curasept (Curasept Prevent®, Curasept S.p.A., Saronno, VA, Italy), with added Kluyveromyces Marxianus Fragilis B0399, colostrum and biotin. The probiotic was taken by patients following the manufacturer's directions via 2 chewable tablets daily, morning and evening, after normal daily oral hygiene, achieving daily average values of B. Lactis HN019 of 2\*107 CFU and Kluyveromyces marxianus fragilis B0399 of 2\*109 CFU.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-12-30
• Last updated: 2025-10-01

Locations

1 site across 1 country: Italy