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

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ClinicalTrials.gov Identifier: NCT02931357
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
Opera Contract Research Organization SRL
Latis S.r.l.
Information provided by (Responsible Party):
Ricerfarma S.r.l

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Teeth Device: Hyaluronic Acid 0.54% Drug: Calgel® Phase 3

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  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Lidocaine 0.33% and Cetylpyridinium Chloride 0.10%




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. redness [ Time Frame: day 0, 3 and 7 ]
    scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2

  5. swelling [ Time Frame: day 0, 3 and 7 ]
    scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2



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Ages Eligible for Study:   3 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931357


Locations
Romania
Opera Contract Research Organization SRL
Timisoara, Timis, Romania, 300209
Sponsors and Collaborators
Ricerfarma S.r.l
Opera Contract Research Organization SRL
Latis S.r.l.
Investigators
Principal Investigator: Serban Rosu, MD Societatea Civile Medicala Dr.Rosu

Publications:

Responsible Party: Ricerfarma S.r.l
ClinicalTrials.gov Identifier: NCT02931357     History of Changes
Other Study ID Numbers: GENG10-12
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ricerfarma S.r.l:
Treatment of teething in infants

Additional relevant MeSH terms:
Hyaluronic Acid
Cetylpyridinium
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Anti-Infective Agents, Local
Anti-Infective Agents