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HyaluHerb Pediatric Oral Gel for Recurrent Aphthous Ulcers and Plaque-Induced Gingivitis in Children: A Two-Cohort
Samah F Mohamed-Ali1, Ahmed A Jasim2, Huda E Ali1
1Department of Pediatric, Orthodontic and Preventive Dentistry, College of Dentistry, Al-Mustansiriya University, Baghdad, Iraq.
Objective:
Recurrent aphthous ulcers (RAU) and plaque-induced gingivitis are among the prevalent pediatric oral conditions. Standard treatments such as chlorhexidine (CHX) and topical corticosteroids have limitations, including unpleasant taste, staining, and poor adherence. This study evaluated HyaluHerb, a novel alcohol-free gel containing 0.2% hyaluronic acid (HA), Aloe vera, and polyphenol-rich herbal extracts (Myrtus communis and Populus euphratica). The present study was aimed to evaluate the efficacy and safety of novel HyaluHerb for treating RAU and gingivitis in children.
Methods:
This was a single-center, double-blind, randomized controlled trial. Cohort A (RAU, n = 99) compared HyaluHerb, HA-only gel, and placebo gel, applied four times daily for 7 days. Cohort B (gingivitis, n = 168) used a double-dummy design to compare HyaluHerb gel, HA-only gel, placebo gel (all twice daily), and 0.12% CHX rinse (twice daily) for 14 days. Primary outcomes were time to ulcer healing and pain score (Cohort A), and change in Gingival Index [gingival index (GI), Cohort B].
Results:
In Cohort A, HyaluHerb significantly accelerated ulcer healing versus placebo (median 5.3 vs. 7.2 days; hazard ratio = 1.73, 95% confidence interval [CI]: 1.16-2.59; P = 0.007) and reduced pain by day 3 (2.5 vs. 4.0; P < 0.001). In Cohort B, HyaluHerb reduced gingival inflammation more than placebo (adjusted difference in ΔGI = -0.20; 95% CI: -0.33 to -0.07; P = 0.004). In an exploratory comparison with CHX (not powered for noninferiority), the adjusted mean difference in GI change (HyaluHerb - CHX) was +0.10, with a one-sided 95% upper confidence bound of +0.15 (prespecified margin), and a supportive per-protocol estimate of +0.14. HyaluHerb demonstrated higher acceptability (P < 0.001) and minimal staining (4.8%) compared with CHX (59.5%).
Conclusion:
HyaluHerb is an effective, well-tolerated, child-friendly treatment for acute pediatric RAU and plaque-induced gingivitis.
