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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02179-30 | Other Identifier | ID-RCB number,ANSM |
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sponsor decision
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| Name | Class |
|---|---|
| Sunstar, Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
| |
| control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral probiotics (L. reuteri) | Dietary Supplement | administration of probiotic containing tablets twice daily after tooth brushing for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation of gingival index (Löe Silness) between baseline and 6 months | At 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevimy AGOSSA | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Salengro - Chu Lille | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | administration of a placebo twice daily after tooth brushing for 3 months |
|
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 |
| D009057 |
| Stomatognathic Diseases |
| D019602 |
| Food and Beverages |