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

Completed

• Conditions: Tooth Eruption Disorder
• Interventions: Device: Teething Ring; Device: Teething Gel

• Registration Number: NCT04879836
• Lead Sponsor: University of Urbino "Carlo Bo"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-06
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Teething Ring	Teething Ring	-
Teething Ring + Teething Gel	Teething Gel	-
Teething Ring + Teething Gel	Teething Ring	-

Primary Outcome Measures

Name	Time	Method
Inappetence	1 month (1 check per week)	5-level Likert scale completed by the paediatrician
Salivation	1 month (1 check per week)	5-level Likert scale completed by the paediatrician
General well-being	1 month (1 check per week)	5-level Likert scale completed by the paediatrician
Unexplained cry	1 month (1 check per week)	5-level Likert scale completed by the paediatrician
Irritability	1 month (1 check per week)	5-level Likert scale completed by the paediatrician
Fever	1 month (1 check per week)	Number of days with fever
Sleep disturbance	1 month (1 check per week)	5-level Likert scale completed by the paediatrician
Gum redness	1 month (1 check per week)	5-level Likert scale completed by the paediatrician

Trial Locations

Locations (1)

University of Urbino Carlo Bo; 🇮🇹 Urbino, Italy