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

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

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

Study Overview

• Status: Completed
• Conditions: Tooth Disease
• Intervention / Treatment: Device: HA BPX V3.3; Other: Dentinox-Gel N

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HA BPX V3.3; A HMWHA gel available in a formulation specificaly designed for use in infants	Device: HA BPX V3.3; medical device containing HA
Active Comparator: Dentinox-Gel N; Gold standard for teething symptoms	Other: Dentinox-Gel N; Anaesthetic gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in gingival swelling	Face, Legs, Activity, Cry and Consolability Pain Assesment Scale	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in crying	Face, Legs, Activity, Cry and Consolability Pain Assesment Scale	7 days

Collaborators and Investigators

• Sponsor: Opera CRO, a TIGERMED Group Company
• Investigators: Principal Investigator: Rosu Serban, MD, SCM Dr. Rosu

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2013
• Primary Completion (Actual): March 31, 2015
• Study Completion (Actual): June 30, 2015

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: paediatric dentistry; teething in infants and children; oral gels
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases
• Other Study ID Numbers: BPX11-13

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