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| Name | Class |
|---|---|
| University of Birmingham | OTHER |
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This study is to compare the effect on oral mucosal desquamation of a non-SLS toothpaste and an SLS-containing toothpaste..
Subjects will use a wash out toothpaste for at least 10 days prior to each leg of the crossover design. Clinical assessment of oral mucosa status will be performed by a trained examiner before supervised product application, 30 minutes after product application and again after 4 days of twice daily brushing with product. Supervised product application consists of cap splint application of allocated toothpaste to maxillary arch followed by brushing whole mouth with toothpaste and swishing with resultant slurry around the mouth.
For visual sloughing evaluation, the oral mucosa will be divided into 12 assessment areas and each area evaluated for severity of sloughing on a 0 to 5 scale.
The following outcomes will be generated from the sloughing data:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Toothpaste containing 0.32%NaF and no sodium lauryl sulphate (SLS) |
|
| Comparator | Active Comparator | Toothpaste containing 0.8% sodium monofluorophosphate (SMFP) and sodium lauryl sulphate (SLS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aggregate number of lesions | Total lesion count aggregated across all subjects | 30 minutes |
| Aggregate number of lesions | Total lesion count aggregated across all subjects | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion severity | Subject level mucosal severity sloughing score | 30 minutes |
| Lesion severity | Subject level mucosal severity sloughing score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iain Chapple, Professor | The University of Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Birmingham | Birmingham | B5 7EG | United Kingdom |
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| ID | Term |
|---|---|
| D009336 | Necrosis |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 4 days |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |