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Medical device study for efficacy and tolerability of a HA gel in the management of teething symptoms
Full 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.
Enrollment
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Volunteers
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:
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
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Interventional model
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54 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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