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

September 30, 2019 updated by: Ricerfarma S.r.l

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 3

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

  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300209
        • Opera Contract Research Organization SRL

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

3 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female infants aged between 6 and 36 months.

  2. Teething diagnosed by the presence of at least 3 of the following clinical symptoms:

    pain, swelling, gingival rush, hyper-salivation, redness, abnormal teeth depth.

  3. At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.
  4. Informed consent form signed by parents or legal representative.
  5. Infants and parents who are in a general position to follow all study requirements

Exclusion Criteria:

  1. Infants in hospitalization and/or immobilization and/or confinement to bed.
  2. Infants with known history of severe renal insufficiency and/or known history of severe cardiac dysfunction and/or liver problems
  3. Use of topical Lidocaine and/or topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within one day before inclusion.
  4. Use of systemic NSAIDs within 3 days before inclusion and/or use of systemic anesthetics within 10 days before.
  5. Concomitant use during the period of study of NSAIDs and/or any anesthetics (obviously Calgel® is allowed in patients randomized in group B, only)
  6. 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.
  7. 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.
  8. Infants simultaneously participating or having participated in the last month before Visit 1 in another clinical trial.
  9. Infants already treated under this protocol.

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic Acid 0.54%
Administration: application of the gel on the gingival tissue, massage it in gently, five to six times a day.
Device: Hyaluronic Acid 0.54%
Administration: application of the gel on the gingival tissue, massage it in gently, five to six times a day
Other Names:
  • Hyaluronic Acid gel 0.54%.
Active Comparator: Calgel®
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®
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.
Other Names:
  • Lidocaine 0.33% and Cetylpyridinium Chloride 0.10%

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Ricerfarma S.r.l

Collaborators

Opera CRO, a TIGERMED Group Company
Latis S.r.l.

Investigators

  • Principal Investigator: Serban Rosu, MD, Societatea Civile Medicala Dr.Rosu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GENG10-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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