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

NCT ID: NCT06752330

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-06-30

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.

Conditions

Orthodontics; Dental Hygiene; Gingivitis and Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Domiciliary oral hygiene with probiotics

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.

Group Type: EXPERIMENTAL

Use of probiotics during oral hygiene at home

Intervention Type: DIETARY_SUPPLEMENT

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.

Domiciliary oral hygiene alone

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Jacopo Lanzetti

Dental Hygienist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU Città della Salute e della Scienza

Torino, Italy, Italy

Countries

Italy

Other Identifiers

0001105

Identifier Type: -

Identifier Source: org_study_id