Effect of Probiotics on the Periodontal Status of Orthodontic Patients (POP)

University Hospital, Lille

Status

Enrolling

Conditions

Periodontal Health

Gingivitis

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Oral probiotics (L. reuteri)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04634201

2019_14

2020-A02179-30 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

116 estimated patients

Sex

All

Ages

12 to 16 years old

Volunteers

No Healthy Volunteers

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 criteria

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)