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

NCT04879836 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2021-07-07

No results posted yet for this study

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

  • Tooth Eruption Disorder

Interventions

DEVICE

Teething Gel

Dosage: application of an even coat of 1mm thickness Frequency: 5 times/day (after main meals and before sleeping) Duration: 4 weeks

DEVICE

Teething Ring

The teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks

Sponsors & Collaborators

  • University of Urbino "Carlo Bo"

    lead OTHER

Principal Investigators

  • Davide Sisti, PhD · University of Urbino "Carlo Bo"

Eligibility

Min Age
2 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879836 on ClinicalTrials.gov