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

BACKGROUND: 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-molecular-weight hyaluronan (HMWHA) for the relief of teething. Results will support the design a future main trial vs. local anesthetic, that is currently the only clinically proven pain reliever. METHODS: This was a pilot, randomized, controlled, multicenter, open-label, and 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, Wallington, UK), or to standard drug (Dentinox®-Gel N; Dentinox, Berlin, Germany) 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. RESULTS: Twenty-seven 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 favor 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. CONCLUSIONS: 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.

Efficacy and safety of a novel vaginal medical device in recurrent bacterial vaginosis: a multicenter clinical trial.

BACKGROUND: The effectiveness of a new vaginal medical device, which contains polycarbophil, 0.04% lauryl glucoside and glycerides (Polybactum®, Effik Italia Spa, Cinisello Balsamo, Milan, Italy), in reducing BV recurrence rate was investigated. METHODS: This was a multicenter, open label, not comparative study. Women over 18 years old affected by recurrent BV were included. The latest episode was diagnosed by Amsel criteria 6-9 days before the start of the study and treated with vaginal metronidazole (gel 0.75% mg for 5 days or ovules 500 mg for 7 days). The recurrence was defined by at least 2 episodes in the previous 12 months. Polybactum® vaginal ovules, day 1-4-7, were started within the 12th and the 24th hour after the end of metronidazole therapy and repeated monthly for 3 cycles. RESULTS: The first 41 patients enrolled were evaluated for an interim analysis 6 months after the study started; 2 patients interrupted the trial, leaving 39 evaluable subjects. The recurrence rate was significantly reduced compared to previous published data (10.26% vs. 40% P<0.001). In 35 patients without recurrence, the assessment of Lactobacillus vaginal flora performed by phase contrast microscopy evidenced a significant improvement form baseline (P=0.022) The investigator global assessment of tolerability was excellent in 38 out of 39 cases. CONCLUSIONS: Our research showed that 3 monthly cycles of Polybactum® ovules administered after one course of metronidazole vaginal therapy can reduce the rate of Bacterial vaginosis recurrence and improve the vaginal milieu, favoring the growth of vaginal lactobacillus species.

Therapeutic approach to pediatric oral disorders.

The promotion of oral health in pediatrics stands as an institutional requirement in countries such as Italy where children's dental disorders still register a high incidence despite high levels of general health. Guidelines indicate the need to target a large age group and stress the relevance of parental education, whom pediatricians and dentists should address to. In this respect, teething is paradigmatic, due to the interactions between inflammation of the gingival mucosa, the possible associations with systemic symptoms as well as the psychological parental component. Teething products include: remedies used in folk medicine (chamomile and rose honey), whose clinical efficacy has not been proved; local anesthetics (lidocaine and benzocaine), easily absorbed by the oral mucosa and able to provide for a rapid, though short-lived relief; salicylates, prescribed by pediatricians in selected cases where the pain and inflammatory component is very high; systemic anti-inflammatory (paracetamol in elixir formulation), prescribed only in particularly serious cases, whereas they are sold over the counter in numerous countries; and - last but not least - film-forming devices containing hyaluronic acid, whose efficacy has been clinically tested in various children disorders of the oral cavity, including teething.