Gingivitis Clinical Trial
— POPOfficial title:
Effect of Probiotics in Addition to Dental Brushing on Gum Inflammation and Oral Microbiota in Patients With Fixed Orthodontic Appliances
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
Status | Recruiting |
Enrollment | 116 |
Est. completion date | March 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 16 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
France | Hop Salengro - Chu Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Sunstar, Inc. |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variation of gingival index (Löe Silness) between baseline and 6 months | At 6 months | ||
Secondary | bleeding on probing (BOP) score (% of BOP sites) | At Baseline, at 3 months and 6 months | ||
Secondary | plaque index (O'leary) | At Baseline, at 3 months and 6 months | ||
Secondary | dysbiosis index | Shannon-weaver, alpha rarefaction, beta diversity | At Baseline, at 3 months and 6 months | |
Secondary | level of salivary markers of inflammation - | At Baseline, at 3 months and 6 months | ||
Secondary | compliance level record | At Baseline, at 3 months and 6 months |
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