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Completed

NCT Number: NCT06752330

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

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.

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Key information

Conditions

Orthodontics Dental Hygiene Gingival Diseases Gingivitis Gingivitis and Periodontal Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

10 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Città della Salute e della Scienza

Torino, Italy, 10126

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Full Mouth Bleeding Score (FMBS)

    Time frame: 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 outcomes

  1. Full Mouth Plaque Score (FMPS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Evaluation of the Effect of a Probiotic in Subjects Undergoing Fixed Orthodontic Appliances With Multibrackets or Clear Aligners: a Single-blind Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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