Effects of a Gum Gel Intended to Treat Signs and Symptoms of Teething

Study Overview
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Brief Summary
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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.

Official Title
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Retrospective Analysis of the Effects of a Gum Gel Intended to Treat Signs and Symptoms of Teething in Infants

Conditions
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Tooth Eruption Disorder

Intervention / Treatment
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* Device: Teething Gel
* Device: Teething Ring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Teething Ring + Teething Gel<br> | Device: Teething Gel<br>* Dosage: application of an even coat of 1mm thickness Frequency: 5 times/day (after main meals and before sleeping) Duration: 4 weeks<br>Device: Teething Ring<br>* The teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks<br>|
| Teething Ring<br> | Device: Teething Ring<br>* The teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gums, paediatric, redness, fever, inappetence, sleep disturbance