Effect of Oxyflower® Gel as an Adjunct in Pericoronitis Treatment: A Randomized, Triple-Blind Clinical Trial

Abstract

Background: Floral and vibrational therapies represent an emerging field in dental therapy, however, good quality clinical research is still needed. The aim of this research was to investigate the effect of Oxyflower® gel as an adjunct in pericoronitis treatment, evaluating clinical parameters and the impact on the quality of life of patients. Methodology: A randomized controlled, triple-blind, longitudinal clinical trial was performed. The sample consisted of 55 participants diagnosed with pericoronitis at the Periodontics and Surgery Clinic of UFVJM. Patients underwent emergency treatment, with local debridement and irrigation with saline solution, followed by topical application of the randomly selected gel: Oxyflower® (OXY, n=19); chlorhexidine gel (CLX, n=17), or placebo (PLC, n=19). In cases of pericoronitis with systemic signs/symptoms, such as fever, malaise, and lymphadenopathy, systemic antibiotic therapy was prescribed one hour before debridement, lasting seven days. Participants received guidance on oral hygiene, and adequacy of the area and were instructed to apply the same gel at home, twice a day for seven days, in addition to being instructed to use analgesics when there was pain. Follow-up was done after 1, 3, 7, 15, 30, 90, and 120 days. After 30 days, the definitive treatment was performed according to the indication: extraction, distal wedge surgery, or follow-up. Participants were followed longitudinally for an additional 90 days, totaling 120 days of follow-up. Pain and quality of life (QOL) were evaluated as primary outcomes. As secondary outcomes: probing depth (PD), bone crest level at the distal of the second molar (BCL), mouth opening (MO), and extent of edema/erythema (EEE) in the pericoronal hood region. Plaque Index (PI), Bleeding Index on Probing (BOP), and lower third molar positioning were also evaluated using panoramic radiography. A comparative analysis was performed between the groups using the chi-square test or Fisher's exact test for categorical variables and ANOVA or Kruskal-Wallis for continuous variables. The Generalized Estimating Equation (GEE) model was used to estimate the differences between groups in pain, QOL, EEE, MO, PI, BOP, PD, and BCL values at each follow-up time. Post-hoc tests of the main effects and interactions were performed using Bonferroni adjustment for multiple comparisons. Results: The GEE model revealed that there was no statistically significant difference between the groups for pain, QOL, EEE, MO, BOP, and PD (p>0.05). However, there was an improvement in clinical parameters and QOL over time, regardless of treatment (p<0.01). For the variables PI and BCL, there was an interaction effect between time and intervention. Conclusion: Oxyflower® gel offered no additional benefit in the treatment of pericoronitis when compared to the chlorhexidine gel or placebo. Local debridement and irrigation with saline solution seem to be sufficient to improve the clinical parameters and QOL of the affected patients.