NCT03423784

Brief Summary

Medical device study for efficacy and tolerability of a HA gel in the management of teething symptoms

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

January 26, 2018

Last Update Submit

May 14, 2018

Conditions

Tooth Disease

Keywords

teething in infants and childrenoral gelspaediatric dentistry

Outcome Measures

Primary Outcomes (1)

  • changes in gingival swelling

    Face, Legs, Activity, Cry and Consolability Pain Assesment Scale

    3 days

Secondary Outcomes (1)

  • changes in crying

    7 days

Study Arms (2)

HA BPX V3.3

EXPERIMENTAL

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

Device: HA BPX V3.3

Dentinox-Gel N

ACTIVE COMPARATOR

Gold standard for teething symptoms

Other: Dentinox-Gel N

Interventions

HA BPX V3.3DEVICE

medical device containing HA

HA BPX V3.3
Dentinox-Gel NOTHER

Anaesthetic gel

Dentinox-Gel N

Eligibility Criteria

Age3 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • Infants and parents who are in a general position to follow all study requirements.
  • Informed consent form signed by parents or legal representative.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • Rosu Serban, MD

    SCM Dr. ROSU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 6, 2018

Study Start

November 15, 2013

Primary Completion

March 31, 2015

Study Completion

June 30, 2015

Last Updated

May 17, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share