Study of a New Medical Device in Gel Formulation Versus Calgel® for the Topical Treatment of Teething in Infants

Study Overview
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Brief Summary
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This is a randomized, open label, parallel-groups, multicenter study. The study will be conducted in three clinical sites. Test Medical Device: 0.54% Hyaluronic Acid rose honey flavour gel medical device class IIa.

Detailed Description
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Due to the potentially serious toxicity that can result from the use of topical anesthetics to relieving the symptoms associated with gingival inflammatory conditions or gums trauma in infant, recently, products containing Hyaluronic Acid have been marketed in Europe. In particular, Ricerfarma is developing several high molecular weight Hyaluronic Acid medical devices characterized by the absence of preservatives, alcohol and dyes; therefore, the administration of these products in infants is safe and can help creating a natural protective layer on the gingival tissue. In previous clinical trials with these high molecular weight Hyaluronic Acid medical devices it was noted a periodontal tissue/fluid balance with accelerated healing and repair properties that could be of interest either for accelerating the wound healing process or for treating the complex physical symptoms (i.e. soreness and swelling of gums, crying, sleeplessness) related to the teething in infants. These data were confirmed by a recent pilot study on 18 infants suffering by teething where the two formulation of the tested high molecular weight Hyaluronic Acid medical device evidenced, at the end of treatment period, for pain, swelling, gingival rush, hyper-salivation and redness a statistically significant reduction from baseline.

Official Title
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A Randomized, Open, Parallel-group Multicenter Study of Efficacy and Tolerability of a New Medical Device in Gel Formulation (Hyaluronic Acid 0.54%) Versus Calgel® for the Topical Treatment of Teething in Infants

Conditions
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Pain Teeth

Intervention / Treatment
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* Device: Hyaluronic Acid 0.54%
* Drug: Calgel®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female infants aged between 6 and 36 months. Teething diagnosed by the presence of at least 3 of the following clinical symptoms: pain, swelling, gingival rush, hyper-salivation, redness, abnormal teeth depth. At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared. Informed consent form signed by parents or legal representative. Infants and parents who are in a general position to follow all study requirements Exclusion Criteria: Infants in hospitalization and/or immobilization and/or confinement to bed. Infants with known history of severe renal insufficiency and/or known history of severe cardiac dysfunction and/or liver problems Use of topical Lidocaine and/or topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within one day before inclusion. Use of systemic NSAIDs within 3 days before inclusion and/or use of systemic anesthetics within 10 days before. Concomitant use during the period of study of NSAIDs and/or any anesthetics (obviously Calgel® is allowed in patients randomized in group B, only) Subjects with known history of allergic or adverse reactions to avian proteins or to HA and to any ingredient of the Medical Device and/or of the comparator on study. Infants whose parents suffer from any form of psychiatric disorder or other condition which, in the opinion of the Investigator, might invalidate the required prescription and/or observation or complicate communication with the subject. Infants simultaneously participating or having participated in the last month before Visit 1 in another clinical trial. Infants already treated under this protocol.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic Acid 0.54%<br>Administration: application of the gel on the gingival tissue, massage it in gently, five to six times a day. | Device: Hyaluronic Acid 0.54%<br>* Administration: application of the gel on the gingival tissue, massage it in gently, five to six times a day<br>* Other names: Hyaluronic Acid gel 0.54%.;|
| Active Comparator: Calgel®<br>Administration: application of the gel on the gingival tissue, massage it in gently, three/four times a day (away from meals). In any case the interval between gel applications must be at least 3 hours. | Drug: Calgel®<br>* Administration: application of the gel on the gingival tissue, massage it in gently, three/four times a day (away from meals). In any case the interval between gel applications must be at least 3 hours.<br>* Other names: Lidocaine 0.33% and Cetylpyridinium Chloride 0.10%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Teething pain | scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2 | day 0, 3 and 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| day pain | scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2 | day 0, 3 and 7 | 
| gingival rush | scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2 | day 0, 3 and 7 | 
| hyper-salivation | scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2 | day 0, 3 and 7 | 
| redness | scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2 | day 0, 3 and 7 | 
| swelling | scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2 | day 0, 3 and 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of teething in infants