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The aim of this exploratory study is to evaluate the efficacy of the tested interdental brush versus comparative interdental brushes in adults with periodontal disease, over a 4-week period.
This study will take place at a single center as an intra-individual, split mouth, randomized, comparative study to evaluate the efficacy of the tested interdental brushes versus the comparative interdental brushes in adults with periodontal disease, over a 4-week period.
3 visits are planned:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test interdental brush | Other | Each subject uses the test interdental brush on one side of the mouth for 4 weeks. |
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| Comparative interdental brush | Other | Each subject uses the comparative interdental brush on the contralateral side of the mouth for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test interdental brush | Other | Interdental brush to be used twice a day during the whole study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect on dental plaque | Dental plaque (%) will be assessed according to the O'Leary method on each side of the mouth. | Change from Visit 1 (Day 1) to Visit 2 (Day 29). |
| Effect on gingival bleeding | Gingival bleeding (%) will be assessed on each side of the mouth. | Change from Visit 1 (Day 1) to Visit 2 (Day 29). |
| Effect on pocket depth | Pocket depth (mm) will be assessed on each side of the mouth. | Change from Visit 1 (Day 1) to Visit 2 (Day 29). |
| Interdental hygiene assessment by subject | Interdental hygiene on each side of the mouth at Visit 2 compared to Visit 1 will be assessed by the subject using a 4-point scale (0: no change, -1: slightly improvement, 2: improvement, 3: significant improvement) | Visit 2 (Day 29). |
| Adverse events recording | Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation | From Visit 1 (Day 1) to Visit 2 (Day 29) |
| Acceptability Questionnaire assessment | Acceptability questionnaire regarding the use of the interdental brushes will be completed by the subject. | Visit 2 (Day 29) |
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Inclusion Criteria:
Non-inclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adeline BACQUEY | Contact | 0534506533 | adeline.bacquey@pierre-fabre.com |
| Name | Affiliation | Role |
|---|---|---|
| Selena TOMA, Pr. | UC Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Intra-individual split-mouth randomized comparative study in adults with periodontal disease.
Subjects enrolled in the study will use the test interdental brush on one side of the mouth and comparative interdental brush on contralateral side of the mouth for 4 weeks.
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| Comparative interdental brush | Other | Interdental brush to be used twice a day during the whole study. |
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