Abstract：
OBJECTIVE: Treatment of periodontitis, a chronic inflammatory disease driven by biofilm dysbiosis, remains challenging due to patients\' poor performance and adherence to the necessary oral hygiene procedures. Novel, artificial intelligence-enabled multimodal-sensing toothbrushes (AI-MST) can guide patients\' oral hygiene practices in real-time and transmit valuable data to clinicians, thus enabling effective remote monitoring and guidance. The aim of this trial was to assess the effect of such a system as an adjunct to clinical practice guideline-conform treatment.
METHODS: This was a single-centre, double-blind, standard-of-care controlled, randomized, parallel-group, superiority trial. Male and female adults with generalized Stage II/III periodontitis were recruited at the Shanghai Ninth People\'s Hospital, China. Subjects received a standard-of-care oral hygiene regimen or a technology-enabled, theory-based digital intervention consisting of an AI-MST and targeted doctor\'s guidance by remote micromessaging. Additionally, both groups received guideline-conform periodontal treatment. The primary outcome was the resolution of inflamed periodontal pockets (≥4 mm with bleeding on probing) at 6 months. The intention-to-treat (ITT) analysis included all subjects who received the allocated treatment and at least one follow-up.
RESULTS: One hundred patients were randomized and treated (50 tests/controls) between 1 February and 30 November 2022. Forty-eight tests (19 females) and 47 controls (16 females) were analysed in the ITT population. At 6 months, the proportion of inflamed periodontal pockets decreased from 80.7% (95% confidence interval [CI] 76.5-84.8) to 52.3% (47.7-57.0) in the control group, and from 81.4% (77.1-85.6) to 44.4% (39.9-48.9) in the test group. The inter-group difference was 7.9% (1.6-14.6, p < .05). Test subjects achieved better levels of oral hygiene (p < .001). No significant adverse events were observed.
CONCLUSIONS: The tested digital health intervention significantly improved the outcome of periodontal therapy by enhancing the adherence and performance of self-performed oral hygiene. The model breaks the traditional model of oral health care and has the potential to improve efficiency and reduce costs (NCT05137392).
METHODS: This was a single-centre, double-blind, standard-of-care controlled, randomized, parallel-group, superiority trial. Male and female adults with generalized Stage II/III periodontitis were recruited at the Shanghai Ninth People\'s Hospital, China. Subjects received a standard-of-care oral hygiene regimen or a technology-enabled, theory-based digital intervention consisting of an AI-MST and targeted doctor\'s guidance by remote micromessaging. Additionally, both groups received guideline-conform periodontal treatment. The primary outcome was the resolution of inflamed periodontal pockets (≥4 mm with bleeding on probing) at 6 months. The intention-to-treat (ITT) analysis included all subjects who received the allocated treatment and at least one follow-up.
RESULTS: One hundred patients were randomized and treated (50 tests/controls) between 1 February and 30 November 2022. Forty-eight tests (19 females) and 47 controls (16 females) were analysed in the ITT population. At 6 months, the proportion of inflamed periodontal pockets decreased from 80.7% (95% confidence interval [CI] 76.5-84.8) to 52.3% (47.7-57.0) in the control group, and from 81.4% (77.1-85.6) to 44.4% (39.9-48.9) in the test group. The inter-group difference was 7.9% (1.6-14.6, p < .05). Test subjects achieved better levels of oral hygiene (p < .001). No significant adverse events were observed.
CONCLUSIONS: The tested digital health intervention significantly improved the outcome of periodontal therapy by enhancing the adherence and performance of self-performed oral hygiene. The model breaks the traditional model of oral health care and has the potential to improve efficiency and reduce costs (NCT05137392).
摘要：
目的：牙周炎的治疗，由生物膜菌群失调引起的慢性炎症性疾病，由于患者表现不佳和坚持必要的口腔卫生程序，仍然具有挑战性。小说,人工智能支持的多模式传感牙刷（AI-MST）可以实时指导患者的口腔卫生实践，并将有价值的数据传送给临床医生，从而实现有效的远程监控和指导。这项试验的目的是评估这种系统作为临床实践指南符合治疗的辅助手段的效果。
方法：这是一个单中心，双盲,护理标准控制，随机化，平行组，优势审判。在上海市第九人民医院招募患有广泛性II/III期牙周炎的男性和女性成年人，中国。受试者接受标准护理口腔卫生方案或技术支持，基于理论的数字干预，由AI-MST和通过远程微消息的目标医生指导组成。此外,两组均接受符合指南的牙周治疗.主要结果是6个月时牙周袋发炎（≥4mm，探查出血）的消退。意向治疗(ITT)分析包括接受分配的治疗和至少一次随访的所有受试者。
结果：在2022年2月1日至11月30日期间，对100名患者进行了随机和治疗（50个测试/对照）。在ITT人群中分析了48个测试（19个女性）和47个对照（16个女性）。6个月时,在对照组中，牙周袋发炎的比例从80.7%（95%置信区间[CI]76.5-84.8）下降到52.3%（47.7-57.0），试验组从81.4%(77.1-85.6)上升到44.4%(39.9-48.9)。组间差异为7.9%（1.6-14.6，p<0.05）。测试对象达到了更好的口腔卫生水平(p<.001)。没有观察到显著的不良事件。
结论：经过测试的数字健康干预措施通过增强自我执行口腔卫生的依从性和表现，显着改善了牙周治疗的结果。该模式打破了传统的口腔保健模式，具有提高效率和降低成本的潜力(NCT05137392)。
方法：这是一个单中心，双盲,护理标准控制，随机化，平行组，优势审判。在上海市第九人民医院招募患有广泛性II/III期牙周炎的男性和女性成年人，中国。受试者接受标准护理口腔卫生方案或技术支持，基于理论的数字干预，由AI-MST和通过远程微消息的目标医生指导组成。此外,两组均接受符合指南的牙周治疗.主要结果是6个月时牙周袋发炎（≥4mm，探查出血）的消退。意向治疗(ITT)分析包括接受分配的治疗和至少一次随访的所有受试者。
结果：在2022年2月1日至11月30日期间，对100名患者进行了随机和治疗（50个测试/对照）。在ITT人群中分析了48个测试（19个女性）和47个对照（16个女性）。6个月时,在对照组中，牙周袋发炎的比例从80.7%（95%置信区间[CI]76.5-84.8）下降到52.3%（47.7-57.0），试验组从81.4%(77.1-85.6)上升到44.4%(39.9-48.9)。组间差异为7.9%（1.6-14.6，p<0.05）。测试对象达到了更好的口腔卫生水平(p<.001)。没有观察到显著的不良事件。
结论：经过测试的数字健康干预措施通过增强自我执行口腔卫生的依从性和表现，显着改善了牙周治疗的结果。该模式打破了传统的口腔保健模式，具有提高效率和降低成本的潜力(NCT05137392)。
