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

NCT06752330 | Completed DMC

• 1 other identifier: 0001105
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

probiotics; Fixed orthodontic; oral hygiene; clear aligners

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Full Mouth Plaque Score (FMPS)

  4 months

Study Arms (2)

Domiciliary oral hygiene with probiotics

EXPERIMENTAL

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

Domiciliary oral hygiene alone

NO INTERVENTION

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.

Interventions

Use of probiotics during oral hygiene at home 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 with probiotics

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

AOU Città della Salute e della Scienza

Torino, Italy, 10126, Italy

Location

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The operator performing the data collection was unaware of the group membership of the evaluated patient
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dental Hygienist

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IT (1)