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Orthodontic patients need supplementary oral hygiene tools in addition to professional oral hygiene. The aim of this study is to evaluate the effects of Bifidobacterium animalis subs. Lactis HN019 on plaque accumulation and gingival bleeding in orthodontic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Domiciliary oral hygiene with probiotics | Experimental | During the first sitting (T0), after checking the inclusion criteria to enter the re-search protocol, a professional oral hygiene session is carried out through the use of ultrasonic inserts, hand instruments, and glycine powder. One month after the first session (T1), FMPS and FMBS are detected. Probiotic administration is discontinued in patients belonging to the test group. At 2 months from baseline (T2), plaque and bleeding indices are recalculated and, for test group patients only, probiotic supply is delivered for 1 month. Then, after 1 month (T3), plaque and bleeding indices are measured and probiotic supply is discontinued. |
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| Domiciliary oral hygiene alone | No Intervention | During the first sitting (T0), after checking the inclusion criteria to enter the re-search protocol, a professional oral hygiene session is carried out through the use of ultrasonic inserts, hand instruments, and glycine powder. All patient is instructed to perform home oral hygiene procedures using a medium-bristle manual toothbrush and fluoride toothpaste (1450 ppm F) with no added anti-plaque or anti-calculus property. Patients are advised against the use of any mouthwash. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of probiotics during oral hygiene at home | Dietary Supplement | The probiotic used in the study is Bifidobacterium Lactis HN019, distributed com-mercially in Italy by Curasept (Curasept Prevent®, Curasept S.p.A., Saronno, VA, Italy), with added Kluyveromyces Marxianus Fragilis B0399, colostrum and biotin. The probiotic was taken by patients following the manufacturer's directions via 2 chewable tablets daily, morning and evening, after normal daily oral hygiene, achieving daily average values of B. Lactis HN019 of 2*107 CFU and Kluyveromyces marxianus fragilis B0399 of 2*109 CFU. |
| Measure | Description | Time Frame |
|---|---|---|
| Full Mouth Bleeding Score (FMBS) | FMBS is a dichotomous index indicating the presence of gingival bleeding on 6 surfaces, the same as FMPS, after light probing. The ratio of surfaces with bleeding to the total of the assessed surfaces is presented as a percentage. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Full Mouth Plaque Score (FMPS) | FMPS is a dichotomous index indicating the presence of bacterial biofilm on 6 tooth surfaces: mesio-vestibular, vestibular, disto-vestibular, disto-palatal/lingual, pala-tal/lingual, and mesio-palatal/lingual. The ratio of surfaces with plaque to the total of the assessed surfaces is presented as a percentage. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Città della Salute e della Scienza | Torino | Italy | 10126 | Italy |
IPD will shared by papers or presentations
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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The operator performing the data collection was unaware of the group membership of the evaluated patient
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