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

July 6, 2021 updated by: Davide Sisti, University of Urbino "Carlo Bo"

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Urbino, Italy, 61029
        • University of Urbino Carlo Bo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Teething Ring + Teething Gel
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
Teething Ring
Device: Teething Ring
The teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Urbino "Carlo Bo"

Investigators

  • Principal Investigator: Davide Sisti, PhD, University of Urbino "Carlo Bo"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniUrb_GumGel_2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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