Clinical Trials Directory

Trials / Completed

CompletedNCT04879836

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
51 (actual)
Sponsor
University of Urbino "Carlo Bo" · Academic / Other
Sex
All
Age
2 Months – 12 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICETeething GelDosage: application of an even coat of 1mm thickness Frequency: 5 times/day (after main meals and before sleeping) Duration: 4 weeks
DEVICETeething RingThe teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks

Timeline

Start date
2018-12-01
Primary completion
2019-06-30
Completion
2019-06-30
First posted
2021-05-10
Last updated
2021-07-07

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04879836. Inclusion in this directory is not an endorsement.