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

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.

Study Overview

• Status: Completed
• Conditions: Orthodontics; Dental Hygiene; Gingivitis and Periodontal Diseases
• Intervention / Treatment: Dietary supplement: Use of probiotics during oral hygiene at home

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Italy
    • Torino, Italy, Italy, 10126
      • AOU Città della Salute e della Scienza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full Mouth Bleeding Score (FMBS)	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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full Mouth Plaque Score (FMPS)	FMPS is a dichotomous index indicating the presence of bacterial biofilm on 6 tooth surfaces: mesio-vestibular, vestibular, disto-vestibular, disto-palatal/lingual, pala-tal/lingual, and mesio-palatal/lingual. The ratio of surfaces with plaque to the total of the assessed surfaces is presented as a percentage.	4 months

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 30, 2024

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: probiotics; oral hygiene; clear aligners; Fixed orthodontic
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Gingivitis
• Other Study ID Numbers: 0001105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will shared by papers or presentations
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No