Gingivitis, Periodontal Health
Conditions
Keywords
Gingivitis, oral microbiota, salivary biomarkers, probiotics
Brief 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
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
Sponsors
University Hospital, Lille
Sunstar, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation of gingival index (Löe Silness) between baseline and 6 months | At 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bleeding on probing (BOP) score (% of BOP sites) | At Baseline, at 3 months and 6 months | — |
| plaque index (O'leary) | At Baseline, at 3 months and 6 months | — |
| dysbiosis index | At Baseline, at 3 months and 6 months | Shannon-weaver, alpha rarefaction, beta diversity |
| level of salivary markers of inflammation - | At Baseline, at 3 months and 6 months | — |
| compliance level record | At Baseline, at 3 months and 6 months | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORKevimy AGOSSA
University Hospital, Lille
Outcome results
None listed