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

NCT04879836 | Completed

• 1 other identifier: UniUrb_GumGel_2021
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gums; redness; fever; paediatric; inappetence; sleep disturbance

Outcome Measures

Primary Outcomes (8)

• Unexplained cry

  5-level Likert scale completed by the paediatrician

  1 month (1 check per week)

• Irritability

  5-level Likert scale completed by the paediatrician

  1 month (1 check per week)

• Sleep disturbance

  5-level Likert scale completed by the paediatrician

  1 month (1 check per week)

• Inappetence

  5-level Likert scale completed by the paediatrician

  1 month (1 check per week)

• Salivation

  5-level Likert scale completed by the paediatrician

  1 month (1 check per week)

• Gum redness

  5-level Likert scale completed by the paediatrician

  1 month (1 check per week)

• Fever

  Number of days with fever

  1 month (1 check per week)

• General well-being

  5-level Likert scale completed by the paediatrician

  1 month (1 check per week)

Study Arms (2)

Teething Ring + Teething Gel

Device: Teething Gel; Device: Teething Ring

Teething Ring

Device: Teething Ring

Interventions

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 + Teething Gel

Teething Ring DEVICE

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

Teething Ring; Teething Ring + Teething Gel

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants, without ethnic limitations, of both sexes and between the ages of 2 and 12 months, affected by teething discomfort but considered otherwise healthy.

You may qualify if:

• Teething discomfort
• Being healthy (except for teething discomfort)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Urbino "Carlo Bo": lead

Study Sites (1)

University of Urbino Carlo Bo

Urbino, 61029, Italy

Location

MeSH Terms

Conditions

Erythema; Fever; Anorexia; Parasomnias

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms, Digestive; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Davide Sisti, PhD

  University of Urbino "Carlo Bo"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 10, 2021
• Study Start: December 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

IT (1)