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| Name | Class |
|---|---|
| University of Nancy | OTHER |
| Elsan | OTHER |
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Gingivitis in pregnant women is a common inflammatory periodontal disease that appears from the third month of pregnancy with an overall prevalence of 35 to 100%. This condition is induced by oral biofilm and exacerbated by increased levels of sex steroid hormones characteristic of pregnancy. Strict bacterial plaque control with both professional and home oral hygiene is essential. Manual toothbrushes require a more specific manual technique for women, while sonic electric toothbrushes, due to their ease of use, might be an excellent for oral individual prophylaxis. Therefore, the question of which type of manual or electric toothbrush might be more effective in reducing gingival inflammation in pregnant women is still unresolved. In literature there are a large number of in vitro clinical studies on this topic, there are currently no clinical studies investigating this long-term clinical comparison.
In this context, this study is a randomized clinical trial consisting of a comparative evaluation between two manual and two sonic electric toothbrushes in the efficacy of the control of plaque in order to reduce gingivitis in women during the period of pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group using sonic toothbrush | Experimental | Patient will be asked to use a sonic toothbrush for 3 months |
|
| Group using hydrosonic toothbrush | Experimental | Patient will be asked to use a hydrosonic toothbrush for 3 months |
|
| Group using manual toothbrush with 5460 strands | Experimental | Patients will be asked to use a manual toothbrush with 5460 strands for 3 months |
|
| Group using manual toothbrush | Placebo Comparator | Patients will be asked to use a manual toothbrush for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonicare DiamondClean 9000 PhilipsĀ® | Device | Brush teeth with the electric toothbrush daily during 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of gingival bleeding from baseline during woman pregnancy | Change of gingival inflammation in pregnant woman using manual or electric toothbrushes in daily practice | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on gingival bleeding | Bleeding on Probing | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) |
| Effect on gingival inflammation | gingival index |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Majorelle | Nancy | France |
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| HydroSonic Easy CuradenĀ® | Device | Brush teeth with the hydrosonic toothbrush daily during 3 months |
|
| Manual toothbrush Oral-B 123 | Device | Brush teeth with the manual toothbrush daily during 3 months |
|
| Manual toothbrush Curaprox CS 5460 | Device | Brush teeth with the manual toothbrush daily during 3 months |
|
| T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) |
| Effect on dental plaque | plaque index | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) |
| Effect on gingival attachment | clinical attachment loss | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) |
| Effect on Periodontal Pocket | Periodontal Pocket Probing Depth | T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) |
| Customer Satisfaction Score |
| T1 (Baseline), T2 (+ 1 month) and T3 (+ 3 months) |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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