Effect of Probiotics on the Periodontal Status of Orthodontic Patients

Last updated: February 7, 2023
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

N/A

Clinical Study ID

NCT04634201
2019_14
2020-A02179-30
  • Ages 12-16
  • All Genders

Study Summary

Gingival inflammation (gingivitis) is commonly reported in teenagers with fixed orthodontic devices (FOD). Indeed, FODs promote the accumulation of plaque and interfere with the efficacy of tooth brushing. According to in vitro and in vivo studies, the administration of oral probiotic bacteria including Lactobacillus reuteri may reduce the number of periodontal pathogens in saliva and dental plaque. A recent systematic review shows a positive effect of probiotics in addition to tooth brushing in the treatment of periodontitis. However, there is insufficient data regarding the effect of probiotics in the prevention of gum diseases. The aim of this double-blind randomized placebo-controlled study is to assess the effect of probiotics, in addition to dental brushing, on gum inflammation and the composition of the oral microbiota in teenagers with fixed orthodontic appliances

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adolescents aged 12 to 16 benefiting from social security coverage
  • in good general health in brushing and taking treatments
  • Have FODs
  • who consent to the study and whose parents have given their consent
  • suitable for orthodontic treatment in view of his oral state

Exclusion

Exclusion Criteria:

  • inability to obtain informed consent
  • use of another probiotic or toothpaste / antiseptic mouthwash ≤ 1 month beforeinclusion
  • allergy or hypersensibiliity to the active substance or to any of the excipientslisted in the Gum® PerioBalance® user guide)
  • no history of antibiotic therapy, antiseptic mouthwash ≤ 1 month before inclusion
  • medical contraindication (immunosuppression, pathology requiring prophylacticantibiotic therapy before dental care)
  • physiological, pathological condition, medication or behavior that may haverepercussions on the oral cavity (eg: pregnancy, diabetes, antiepileptics, tobacco)
  • oral state requiring other priority care (untreated cavities, untreated activeperiodontitis, progressive recession)

Study Design

Total Participants: 116
Study Start date:
March 23, 2022
Estimated Completion Date:
March 31, 2024

Connect with a study center

  • Hop Salengro - Chu Lille

    Lille, 59037
    France

    Active - Recruiting

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