Tooth Eruption Disorder
Conditions
Keywords
gums, redness, fever, paediatric, inappetence, sleep disturbance
Brief summary
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.
Interventions
DEVICETeething Gel
Dosage: application of an even coat of 1mm thickness Frequency: 5 times/day (after main meals and before sleeping) Duration: 4 weeks
DEVICETeething Ring
The teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks
Sponsors
University of Urbino Carlo Bo
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
* Teething discomfort * Being healthy (except for teething discomfort)
Exclusion criteria
* Being placed on one of the following therapies in the 45 days prior to the beginning of the study: immunosuppressive, cytotoxic, cortisone, antibiotics, antifungal and hormone therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unexplained cry | 1 month (1 check per week) | 5-level Likert scale completed by the paediatrician |
| Irritability | 1 month (1 check per week) | 5-level Likert scale completed by the paediatrician |
| Sleep disturbance | 1 month (1 check per week) | 5-level Likert scale completed by the paediatrician |
| Inappetence | 1 month (1 check per week) | 5-level Likert scale completed by the paediatrician |
| Salivation | 1 month (1 check per week) | 5-level Likert scale completed by the paediatrician |
| Gum redness | 1 month (1 check per week) | 5-level Likert scale completed by the paediatrician |
| Fever | 1 month (1 check per week) | Number of days with fever |
| General well-being | 1 month (1 check per week) | 5-level Likert scale completed by the paediatrician |
Countries
Italy
Outcome results
None listed