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

Not Applicable

Completed

• Conditions: Orthodontics; Dental Hygiene; Gingivitis and Periodontal Diseases

• Registration Number: NCT06752330
• Lead Sponsor: University of Turin, Italy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-11-30
• Study Completion: 2024-03-15
• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-29
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Full Mouth Bleeding Score (FMBS)	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.

Secondary Outcome Measures

Name	Time	Method
Full Mouth Plaque Score (FMPS)	4 months	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.

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza; 🇮🇹 Torino, Italy