Tooth Eruption DisorderNCT04879836
Effects of a Gum Gel Intended to Treat Signs and Symptoms of Teething
An observational study of Tooth Eruption Disorder, run by University of Urbino "Carlo Bo" at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 months
- Conditions the study is for
- Tooth Eruption Disorder
- What is being tested?
- Teething Gel and Teething Ring
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Teething discomfort
- Being healthy (except for teething discomfort)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tooth Eruption Disorder
- Being tested
- Teething Gel, Teething Ring
- Keywords
- gums, redness, fever, paediatric, inappetence, sleep disturbance
- Medical subject headings
- Erythema, Fever, Anorexia, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teething GelDevice
Dosage: application of an even coat of 1mm thickness Frequency: 5 times/day (after main meals and before sleeping) Duration: 4 weeks
Teething RingDevice
The teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Teething Ring + Teething Gel | Not described Receives: Device: Teething Gel; Device: Teething Ring | |
| Teething Ring | Not described Receives: Device: Teething Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexplained cry
5-level Likert scale completed by the paediatrician
Measured: 1 month (1 check per week)
Irritability
5-level Likert scale completed by the paediatrician
Measured: 1 month (1 check per week)
Sleep disturbance
5-level Likert scale completed by the paediatrician
Measured: 1 month (1 check per week)
Inappetence
5-level Likert scale completed by the paediatrician
Measured: 1 month (1 check per week)
Salivation
5-level Likert scale completed by the paediatrician
Measured: 1 month (1 check per week)
Gum redness
5-level Likert scale completed by the paediatrician
Measured: 1 month (1 check per week)
Fever
Number of days with fever
Measured: 1 month (1 check per week)
General well-being
5-level Likert scale completed by the paediatrician
Measured: 1 month (1 check per week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Dec 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Eruption DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Urbino "Carlo Bo"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Sisti, University of Urbino "Carlo Bo"
- Investigators
- Davide Sisti, PhD, Principal investigator, University of Urbino "Carlo Bo"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879836
- Sponsor's protocol ID
- UniUrb_GumGel_2021
- Status last verified
- Jul 2021
- First submitted
- 4 May 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Effects of a Gum Gel Intended to Treat Signs and Symptoms of Teething in Infants
- ClinicalTrials.gov ID
- NCT04879836
- Acronym / sponsor ID
- UniUrb_GumGel_2021
- Conditions
- Tooth Eruption Disorder
- Keywords
- gums, redness, fever, paediatric, inappetence, sleep disturbance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Urbino "Carlo Bo"University, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teething Ring + Teething Gel | – | Device: Teething Gel, Device: Teething Ring |
| Teething Ring | – | Device: Teething Ring |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Teething discomfort
- Being healthy (except for teething discomfort)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teething GelDosage: application of an even coat of 1mm thickness Frequency: 5 times/day (after main meals and before sleeping) Duration: 4 weeks | Device | Teething Ring + Teething Gel |
| Teething RingThe teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks | Device | Teething Ring, Teething Ring + Teething Gel |
Primary outcome
Unexplained cry
Time frame: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Irritability
Time frame: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Sleep disturbance
Time frame: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Inappetence
Time frame: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Salivation
Time frame: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Gum redness
Time frame: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Fever
Time frame: 1 month (1 check per week)
Number of days with fever
General well-being
Time frame: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide Sisti, PhD principal investigator
University of Urbino "Carlo Bo"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Eruption Disorder, run by University of Urbino "Carlo Bo" at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexplained cry (time frame: 1 month (1 check per week)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.