Denis Frederic, Rat Corinne, Cros Lucie, Bertaud Valerie, El-Hage Wissam, Jonval Lysiane, Soudry-Faure Agnès
Faculty of Dentistry, Tours University, 37000 Tours, France.
EA 75-05 Education, Ethics, Health, Faculty of Medicine, François-Rabelais University, 37000 Tours, France.
Healthcare (Basel). 2023 Jul 5;11(13):1947. doi: 10.3390/healthcare11131947.
The oral health of people with schizophrenia (PWS) is very poor, suggesting a need for oral health promotion programmes with a high level of evidence. The aim of the EBENE study (Clinicaltrials.gov: NCT02512367) was to develop and evaluate the effectiveness of a multidisciplinary therapeutic educational programme in oral health (TEPOH) for PWS.
A multicentre cluster randomised controlled trial, with outpatient psychiatry centres as the unit of randomisation, was designed to compare the effectiveness of TEPOH (intervention group) versus standard care (control group). The trial was conducted in 26 outpatient psychiatry centres in France (14 in the intervention group, 12 in the control group). Eligible patients with a diagnosis of schizophrenia were enroled between 2016 and 2020 and followed for 6 months. The TEPOH group received a multicomponent intervention (comprising an introductory session, three educational sessions, and a debriefing session). The primary endpoint was the evaluation of periodontal disease as a community periodontal index (CPI) score ≥ 3 at Month 6. The trial was completed using a qualitative approach based on semi-structured interviews with caregivers conducted between July 2018 and December 2019. The trial was stopped early due to difficulties in recruiting patients.
Overall, 81 patients (of 250 planned) were included, and 54 patients completed the trial: 40 in the TEPOH group and 14 in the control group. At baseline, the percentage of CPI ≥ 3 was 42.5% in the TEPOH group and 9.1% in the control group. At Month 6, the percentage of CPI ≥ 3 was 20% in the TEPOH group and 14.3% in the control group. The qualitative evaluation underlined that the professionals emphasised the "seriousness" and "assiduity" of the patients' participation in this programme and that the TEPOH reinforced carers' investment in oral hygiene. It also highlighted structural factors (lack of resources for professionals, lack of teeth in PWS, COVID-19 pandemic) that may have exacerbated the difficulties with enrolment and follow-up.
The effectiveness of this TEPOH, developed for PWS as part of the EBENE study, has not been demonstrated. Certain aspects of the programme's content and implementation need to be reconsidered. In particular, an adapted subjective measurement scale should be developed.
精神分裂症患者（PWS）的口腔健康状况很差，这表明需要有高水平证据支持的口腔健康促进项目。EBENE研究（Clinicaltrials.gov：NCT02512367）的目的是为PWS开发并评估多学科口腔健康治疗性教育项目（TEPOH）的有效性。
设计了一项多中心整群随机对照试验，以门诊精神科中心作为随机分组单位，比较TEPOH（干预组）与标准护理（对照组）的有效性。该试验在法国的26个门诊精神科中心进行（14个在干预组，12个在对照组）。2016年至2020年期间纳入了符合条件的精神分裂症诊断患者，并随访6个月。TEPOH组接受了多组分干预（包括一次介绍会、三次教育会和一次汇报会）。主要终点是在第6个月时以社区牙周指数（CPI）评分≥3来评估牙周疾病。该试验采用定性方法完成，基于2018年7月至2019年12月期间对护理人员进行的半结构化访谈。由于招募患者困难，试验提前终止。
总体而言，纳入了81名患者（计划纳入250名），54名患者完成了试验：TEPOH组40名，对照组14名。在基线时，TEPOH组CPI≥3的百分比为42.5%，对照组为9.1%。在第6个月时，TEPOH组CPI≥3的百分比为20%，对照组为14.3%。定性评估强调，专业人员强调了患者参与该项目的“认真程度”和“勤勉态度”，并且TEPOH加强了护理人员在口腔卫生方面的投入。它还突出了可能加剧招募和随访困难的结构性因素（专业人员资源不足、PWS牙齿缺失、新冠疫情）。
作为EBENE研究的一部分为PWS开发的这个TEPOH的有效性尚未得到证实。该项目内容和实施的某些方面需要重新考虑。特别是，应该开发一种适应性主观测量量表。
