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

U

University of Urbino "Carlo Bo"

Status

Completed

Conditions

Tooth Eruption Disorder

Treatments

Device: Teething Ring
Device: Teething Gel

Study type

Observational

Funder types

Other

Identifiers

NCT04879836
UniUrb_GumGel_2021

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

2 to 12 months old

Volunteers

No Healthy Volunteers

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

Trial design

51 participants in 2 patient groups

Teething Ring + Teething Gel
Treatment:
Device: Teething Ring
Device: Teething Gel
Teething Ring
Treatment:
Device: Teething Ring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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