New medical device coating mouth gel for temporary relief of teething symptoms: a pilot randomised, open-label, controlled study.

Abstract

This study verified the feasibility of the monthly recruitment rate, tested the Face, Legs, Activity, Cry and Consolability Pain Assessment Tool (FLACC) for pain in infants and collected preliminary efficacy and safety data of a new proprietary oral gel formulation of high-molecularweight hyaluronan (HMWHA) for the relief of teething. Results will support the design a future main trial vs local anaesthetic, that is currently the only clinically proven pain reliever. This was a pilot, randomised, controlled, multicentre, open-label, parallel-group trial. It was performed in two Romanian clinics recruiting infants from 3 to 36 months. Teething diagnosis was based on a minimum of three symptoms such as: local pain, swelling, erythema, hyper salivation and depth characteristics of unerupted tooth. Absence of subcutaneous mucosal laceration was also required. The children were assigned either to HMWHA (HABPX V 3.3, Bioplax Ltd, UK), or to standard drug (Dentinox®-Gel N) and treated for 7 consecutive days. Investigators recorded the primary endpoints: swelling, redness and pain (by FLACC method), on days 0, 3 and 7. Changes in crying, mouth spasms, salivation, local pain, swelling, and redness were the secondary endpoints, recorded daily by the parents, on diary cards. Tolerability was assessed on day 14, too. 27 Infants were allocated in HMWHA, and 30 in standard drug. Enrolment rate was 9 patients/month/site. A significant reduction for HMWHA group was evidenced in pain, swelling (from day 0 to 7, p = 0.034 between groups), redness (from day 0 to 3, p = 0.045 and from day 0 to 7, p < 0.001 between groups) and confirmed by the parents' diary records. Pain measurements obtained by FLACC method are consistent with the data belonging to other parameters. Investigator's global assessment of performance was in favour of the HMWHA (p < 0.005). Only two patients, both belonging to standard drug group, experienced adverse events (fever, not related to treatment) and dropped out of the study. The results solve the feasibility questions and clearly evidence the performance of HABPX V 3.3 in teething symptoms, exceeding the objectives of a simple pilot trial to some extent. Coating oral gels containing HMWHA could be a therapeutic solution for both parents and physicians in managing the irritation and pain resulting from tooth eruption in children.