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

University of Turin, Italy60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Orthodontics Dental Hygiene Gingivitis and Periodontal Diseases

Interventions

Use of probiotics during oral hygiene at homeDIETARY_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.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 30 Years

Medical Language ↔ Plain English

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.

Locations (1)

AOU Città della Salute e della Scienza

Torino, Italy, Italy

Outcomes

Primary Outcomes

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.

Time frame: 4 months

Secondary Outcomes

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.

Time frame: 4 months

Data from ClinicalTrials.gov

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