RecruitingNot ApplicableNCT04634201

Effect of Probiotics on the Periodontal Status of Orthodontic Patients

Effect of Probiotics in Addition to Dental Brushing on Gum Inflammation and Oral Microbiota in Patients With Fixed Orthodontic Appliances


Sponsor

University Hospital, Lille

Enrollment

116 participants

Start Date

Mar 23, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 16 Years

Inclusion Criteria5

  • 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 Criteria7

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

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Interventions

DIETARY_SUPPLEMENTOral probiotics (L. reuteri)

administration of probiotic containing tablets twice daily after tooth brushing for 3 months

DIETARY_SUPPLEMENTPlacebo

administration of a placebo twice daily after tooth brushing for 3 months


Locations(1)

Hop Salengro - Chu Lille

Lille, France

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NCT04634201


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