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Performance and Tolerability of a New Medical Device Gel, a Randomized, Open Label, Parallel-group, Multicentre Study

Primary Purpose

Tooth Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HA BPX V3.3
Dentinox-Gel N
Sponsored by
Opera CRO, a TIGERMED Group Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tooth Disease focused on measuring teething in infants and children, oral gels, paediatric dentistry

Eligibility Criteria

3 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female infants aged between 3 and 36 months.

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

    • pain
    • swelling
    • hyper-salivation
    • redness
    • abnormal teeth depth.
  3. At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.
  4. Infants and parents who are in a general position to follow all study requirements.
  5. Informed consent form signed by parents or legal representative.

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 oral Lidocaine, other topical oral anesthetic products 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 other anesthetics (except Dentinox®-Gel N, for subjects allocated to group II of treatment).
  6. Subjects with known family history of allergic or adverse reactions to drugs or substances.
  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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    HA BPX V3.3

    Dentinox-Gel N

    Arm Description

    A HMWHA gel available in a formulation specificaly designed for use in infants

    Gold standard for teething symptoms

    Outcomes

    Primary Outcome Measures

    changes in gingival swelling
    Face, Legs, Activity, Cry and Consolability Pain Assesment Scale

    Secondary Outcome Measures

    changes in crying
    Face, Legs, Activity, Cry and Consolability Pain Assesment Scale

    Full Information

    First Posted
    January 26, 2018
    Last Updated
    May 14, 2018
    Sponsor
    Opera CRO, a TIGERMED Group Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03423784
    Brief Title
    Performance and Tolerability of a New Medical Device Gel, a Randomized, Open Label, Parallel-group, Multicentre Study
    Official Title
    Performance and Tolerability of a New Medical Device Coating Gel for the Temporary Relief of Teething Symptoms: a Randomized, Open Label, Parallel-group, Multicentre Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 15, 2013 (Actual)
    Primary Completion Date
    March 31, 2015 (Actual)
    Study Completion Date
    June 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Opera CRO, a TIGERMED Group Company

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Medical device study for efficacy and tolerability of a HA gel in the management of teething symptoms
    Detailed Description
    Due to the potential toxicity that can result from the use of topical anesthetics to relieve the symptoms associated with gingival inflammatory conditions or gums trauma in infant, recently, products containing Hyaluronic Acid (HA) have been marketed in Europe. In particular, Bioplax Limited is developing several high molecular weight HA 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 HA 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 HA medical device evidenced, at the end of treatment period, a statistically significant reduction of pain, swelling, gingival rush, hyper-salivation and redness, from baseline.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Disease
    Keywords
    teething in infants and children, oral gels, paediatric dentistry

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HA BPX V3.3
    Arm Type
    Experimental
    Arm Description
    A HMWHA gel available in a formulation specificaly designed for use in infants
    Arm Title
    Dentinox-Gel N
    Arm Type
    Active Comparator
    Arm Description
    Gold standard for teething symptoms
    Intervention Type
    Device
    Intervention Name(s)
    HA BPX V3.3
    Intervention Description
    medical device containing HA
    Intervention Type
    Other
    Intervention Name(s)
    Dentinox-Gel N
    Intervention Description
    Anaesthetic gel
    Primary Outcome Measure Information:
    Title
    changes in gingival swelling
    Description
    Face, Legs, Activity, Cry and Consolability Pain Assesment Scale
    Time Frame
    3 days
    Secondary Outcome Measure Information:
    Title
    changes in crying
    Description
    Face, Legs, Activity, Cry and Consolability Pain Assesment Scale
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    36 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female infants aged between 3 and 36 months. Teething diagnosed by the presence of at least 3 of the following clinical symptoms: pain swelling hyper-salivation redness abnormal teeth depth. At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared. Infants and parents who are in a general position to follow all study requirements. Informed consent form signed by parents or legal representative. 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 oral Lidocaine, other topical oral anesthetic products 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 other anesthetics (except Dentinox®-Gel N, for subjects allocated to group II of treatment). Subjects with known family history of allergic or adverse reactions to drugs or substances. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rosu Serban, MD
    Organizational Affiliation
    SCM Dr. ROSU
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Performance and Tolerability of a New Medical Device Gel, a Randomized, Open Label, Parallel-group, Multicentre Study

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