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Teething discomfort is a widespread disorder affecting a very high percentage of infants. The use of hyaluronic acid gels has been shown in the last 20 years to be an effective tool, generally devoid of side effects, in reducing oral mucosal inflammation in adults. Its effectiveness in infants is affected by the strength of hyaluronic acid retention over the oral mucosa. This is in turn affected by formulation and may vary between different products due to the different ingredients used. In this study, the results collected by monitoring the paediatric experience regarding a newly developed HA-based medical device, intended to counteract teething discomfort in infants, will be reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teething Ring + Teething Gel |
| ||
| Teething Ring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teething Gel | Device | Dosage: application of an even coat of 1mm thickness Frequency: 5 times/day (after main meals and before sleeping) Duration: 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unexplained cry | 5-level Likert scale completed by the paediatrician | 1 month (1 check per week) |
| Irritability | 5-level Likert scale completed by the paediatrician | 1 month (1 check per week) |
| Sleep disturbance | 5-level Likert scale completed by the paediatrician | 1 month (1 check per week) |
| Inappetence | 5-level Likert scale completed by the paediatrician | 1 month (1 check per week) |
| Salivation | 5-level Likert scale completed by the paediatrician | 1 month (1 check per week) |
| Gum redness | 5-level Likert scale completed by the paediatrician | 1 month (1 check per week) |
| Fever | Number of days with fever | 1 month (1 check per week) |
| General well-being | 5-level Likert scale completed by the paediatrician | 1 month (1 check per week) |
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Inclusion Criteria:
Exclusion Criteria:
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Infants, without ethnic limitations, of both sexes and between the ages of 2 and 12 months, affected by teething discomfort but considered otherwise healthy.
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| Name | Affiliation | Role |
|---|---|---|
| Davide Sisti, PhD | University of Urbino "Carlo Bo" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Urbino Carlo Bo | Urbino | 61029 | Italy |
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| ID | Term |
|---|---|
| D004890 | Erythema |
| D005334 | Fever |
| D000855 | Anorexia |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| Teething Ring | Device | The teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
| D012817 | Signs and Symptoms, Digestive |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |