An observational study in Tooth Eruption Disorder, sponsored by University of Urbino "Carlo Bo". Completed at 1 site in Italy. Open to participants aged 2 Months to 12 Months. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by University of Urbino "Carlo Bo" · Observational
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.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's enrollment of 51 is above the median of 40 across 11 observational studies indexed under Erythema.
Browse Erythema studies →University of Urbino "Carlo Bo" is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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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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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Teething Gel · Device: Teething Ring
Device: Teething Ring
Dosage: application of an even coat of 1mm thickness Frequency: 5 times/day (after main meals and before sleeping) Duration: 4 weeks
The teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks
Unexplained cry
5-level Likert scale completed by the paediatrician
Time frame: 1 month (1 check per week)
Irritability
5-level Likert scale completed by the paediatrician
Time frame: 1 month (1 check per week)
Sleep disturbance
5-level Likert scale completed by the paediatrician
Time frame: 1 month (1 check per week)
Inappetence
5-level Likert scale completed by the paediatrician
Time frame: 1 month (1 check per week)
Salivation
5-level Likert scale completed by the paediatrician
Time frame: 1 month (1 check per week)
Gum redness
5-level Likert scale completed by the paediatrician
Time frame: 1 month (1 check per week)
Fever
Number of days with fever
Time frame: 1 month (1 check per week)
General well-being
5-level Likert scale completed by the paediatrician
Time frame: 1 month (1 check per week)
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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University of Urbino "Carlo Bo"