4. Discussion
traumatic injuries, inflammation, OI, gingivitis, pain, OIs
ADVERSE EVENTS, INFLAMMATION, GINGIVAL BLEEDING, GINGIVITIS, DENTAL PLAQUE, OIS, PLAQUE, HYPERSENSITIVITY SYMPTOMS, DENTIN HYPERSENSITIVITY
This study evaluated the efficacy and safety of oral irrigators with broader range of pressures in removing plaque and relieving gingivitis. The test group showed significant improvement in plaque and gingivitis indices than the control group. Higher irrigation pressures significantly correlated with the reduction in percentage of BOP%. The OI may be associated with transient gingival bleeding without causing significantly higher of pain or dentin hypersensitivity symptoms. Both intention-to-treat-based and per-protocol analyses were performed for efficacy evaluation to obtain more accurate results. The per-protocol analysis tends to exaggerate the treatment effect, and the results obtained from the intention-to-treat-based analysis more closely represent clinical practice and actual effectiveness [At baseline, all clinical parameters were similar in both groups. After 12 weeks, dental plaque and gingival inflammation were significantly improved in the test group compared with the control group in FAS and PPS, indicating that OIs effectively controlled plaque and relieved gingival inflammation. Significantly lower gingival inflammation indices in the test group were also observed at 4 weeks and 8 weeks. Compared to manual toothbrushing alone, the OIs group was significantly more effective in controlling gingival inflammation, which is consistent with the findings of most studies [The reduction in percentage of all gingival inflammation-related indices and plaque index in the test group were also significantly higher compared with control group in FAS and PPS. During the 12 weeks follow-up, a decreasing trend of gingival inflammation-related indices was observed in both groups. However, plaque in both groups showed an upward trend after the 4 weeks visit, with gingival inflammation remaining relatively low, which may be explained by the previous study’s findings [As shown in The irrigation pressure seems to be positively correlated with the efficacy of OIs in relieving gingival inflammation. However, the traumatic injuries that may be associated with high-pressure water flow generated by the OIs have also gained attention [Regarding safety, previous research has investigated a variety of systemic and soft tissue-related indicators and showed that OIs are generally not deleterious to people in good general health [Similar adverse events were found in the two groups. Despite the fact that transient gingival bleeding was found to be likely associated with OIs, gingival bleeding is considered one of the common symptoms of gingivitis [Oral irrigation appears to be an effective adjunct in managing gingivitis. Several mechanisms may be involved. For instance, OIs may remove food deposits and interfere with plaque maturation by flushing loosely adhered plaques [In this study, we evaluated the efficacy of the OIs in gingivitis patients based on both intention-to-treat and per-protocol analysis. We also analyzed the relationship between its efficacy and irrigation pressure. In terms of safety, we analyzed the relationship between OIs and self-reported symptoms of pain and dentin hypersensitivity using the VAS scale for the first time. However, there are still limitations in this study. For instance, we did not use other interdental cleaning tools (e.g., flossing and interdental brushes) for comparison with the efficacy of OIs. The superiority trials between OIs and other interdental cleaning tools are needed in the future.