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Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. This condition has multiple effects on the orofacial region that is involved in approximately 80% of the patients with a significant impact on the quality of life.
The aim of this randomized single-blind study is to evaluate the impact of the use of a specific oral hygiene instrumentation (sonic toothbrush and water flosser with a large handle) compared to "standard" toothbrushing with a manual toothbrush on the gingival health among patients with systemic sclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Manual toothbrush | Active Comparator |
| |
| Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra) | Experimental |
| |
| Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra) | Experimental |
| |
| Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual toothbrush | Device | Patients in group 1 (''reference procedure'') receive a manual toothbrush with a small compact head to facilitate access to the posterior teeth and soft bristles. |
| Measure | Description | Time Frame |
|---|---|---|
| Changing of plaque index between baseline, week 2 and week 4 | day 0, week 2 and week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie JUNG | Contact | 00333.88.11.69.56 | sophie.jung1@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de parodontologie | Recruiting | Strasbourg | France |
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| Manual toothbrush and water flosser (Philips Sonicare AirFloss) | Device | - Group 2 patients receive a manual toothbrush with a small, compact head for easy access to the posterior teeth and soft bristles. They also receive a Philips brand interdental microjet (Philips Sonicare AirFloss Ultra) which must be filled with water. |
|
| Sonic toothbrush | Device | - Group 3 patients receive a rechargeable sonic electric toothbrush from Philipps with an integrated excess pressure sensor and a compact toothbrush head for easy access to the posterior teeth. |
|
| Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss) | Device | - Group 4 patients receive a Philips Sonicare ProtectiveClean rechargeable sonic electric toothbrush with an integrated excess pressure sensor and 2 compact toothbrush heads for easy access to the posterior teeth. They also receive an interdental microjet from Philips (Philips Sonicare AirFloss Ultra) which must be filled with water. |
|
| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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