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

University of Turin, Italy1 site in 1 country60 target enrollmentJanuary 1, 2025

ConditionsOrthodontics Dental Hygiene Gingivitis and Periodontal Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Orthodontics
Sponsor: University of Turin, Italy
Enrollment: 60
Locations: 1
Primary Endpoint: Full Mouth Bleeding Score (FMBS)
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 1, 2025

End Date

June 30, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Turin, Italy

Responsible Party

Principal Investigator

Jacopo Lanzetti

Dental Hygienist

University of Turin, Italy

Eligibility Criteria

Inclusion Criteria

•age range of 10 to 30 years old;
•good general health;
•patients undergoing fixed multibracket orthodontic treatment;
•patients undergoing invisible aligner orthodontic treatment.

Exclusion Criteria

•physical, mental or motor disabilities;
•systemic conditions that influence the progression of gingivitis;
•presence of non-plaque-induced gingivitis;
•known allergies;
•smokers (if more than 5 cigarettes per day);
•use of antibiotics, anti-inflammatories, or probiotics in the 6 months prior to recruitment.

Outcomes

Primary Outcomes

Full Mouth Bleeding Score (FMBS)

Time Frame: 4 months

FMBS is a dichotomous index indicating the presence of gingival bleeding on 6 surfaces, the same as FMPS, after light probing. The ratio of surfaces with bleeding to the total of the assessed surfaces is presented as a percentage.