NCT03423784

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Opera CRO, a TIGERMED Group Company · Academic / Other
• Sex: All
• Age: 3 Months – 36 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Tooth Disease

Interventions

Type	Name	Description
DEVICE	HA BPX V3.3	medical device containing HA
OTHER	Dentinox-Gel N	Anaesthetic gel

Timeline

• Start date: 2013-11-15
• Primary completion: 2015-03-31
• Completion: 2015-06-30
• First posted: 2018-02-06
• Last updated: 2018-05-17