Effect of Probiotics on the Periodontal Status of Orthodontic Patients

Study Overview
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Brief Summary
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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

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

Conditions
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Periodontal Health, Gingivitis

Intervention / Treatment
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* Dietary Supplement: Oral probiotics (L. reuteri)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Dietary Supplement: Oral probiotics (L. reuteri)<br>* administration of probiotic containing tablets twice daily after tooth brushing for 3 months<br>|
| Sham Comparator: control group<br> | Dietary Supplement: Placebo<br>* administration of a placebo twice daily after tooth brushing for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of gingival index (Löe Silness) between baseline and 6 months |  | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Shannon-weaver, alpha rarefaction, beta diversity | At Baseline, at 3 months and 6 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingivitis, oral microbiota, salivary biomarkers, probiotics