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

University of Turin

Status: Completed

Conditions: Orthodontics; Dental Hygiene; Gingivitis and Periodontal Diseases

Treatments: Dietary Supplement: Use of probiotics during oral hygiene at home

Study type: Interventional

Funder types: Other

Identifiers

NCT06752330

0001105

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 10 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Domiciliary oral hygiene with probiotics

Experimental group

Description:

During the first sitting (T0), after checking the inclusion criteria to enter the re-search protocol, a professional oral hygiene session is carried out through the use of ultrasonic inserts, hand instruments, and glycine powder. One month after the first session (T1), FMPS and FMBS are detected. Probiotic administration is discontinued in patients belonging to the test group. At 2 months from baseline (T2), plaque and bleeding indices are recalculated and, for test group patients only, probiotic supply is delivered for 1 month. Then, after 1 month (T3), plaque and bleeding indices are measured and probiotic supply is discontinued.

Treatment:

Dietary Supplement: Use of probiotics during oral hygiene at home

Domiciliary oral hygiene alone

No Intervention group

Description:

During the first sitting (T0), after checking the inclusion criteria to enter the re-search protocol, a professional oral hygiene session is carried out through the use of ultrasonic inserts, hand instruments, and glycine powder. All patient is instructed to perform home oral hygiene procedures using a medium-bristle manual toothbrush and fluoride toothpaste (1450 ppm F) with no added anti-plaque or anti-calculus property. Patients are advised against the use of any mouthwash.