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OpenTrials
Completed

NCT Number: NCT04879836

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

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.

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Key information

Conditions

Tooth Eruption Disorder Anorexia Body Temperature Changes Erythema Fever Mental Disorders Nervous System Diseases Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Sleep Wake Disorders

Age range

2 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Urbino Carlo Bo

Urbino, 61029, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teething Gel

Device

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

Teething Ring

Device

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

Primary outcomes

  1. Unexplained cry

    Time frame: 1 month (1 check per week)

    5-level Likert scale completed by the paediatrician

  2. Irritability

    Time frame: 1 month (1 check per week)

    5-level Likert scale completed by the paediatrician

  3. Sleep disturbance

    Time frame: 1 month (1 check per week)

    5-level Likert scale completed by the paediatrician

  4. Inappetence

    Time frame: 1 month (1 check per week)

    5-level Likert scale completed by the paediatrician

  5. Salivation

    Time frame: 1 month (1 check per week)

    5-level Likert scale completed by the paediatrician

  6. Gum redness

    Time frame: 1 month (1 check per week)

    5-level Likert scale completed by the paediatrician

  7. Fever

    Time frame: 1 month (1 check per week)

    Number of days with fever

  8. General well-being

    Time frame: 1 month (1 check per week)

    5-level Likert scale completed by the paediatrician

Sponsors and collaborators

Lead sponsor

University of Urbino "Carlo Bo"

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 10, 2021
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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