Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians University Munich, Germany, Munich, Germany.
Institute and Clinic for Occupational, Social and Environmental Medicine, University Hospital, Ludwig-Maximilians University Munich, Germany, Munich, Germany.
Trials. 2023 Feb 23;24(1):139. doi: 10.1186/s13063-023-07135-0.
Periodontal disease and lung function impairment were found to be associated with low-grade systemic or local inflammation, and it might be that gingival/periodontal inflammation triggers lung function due to systemic inflammation or the transfer of oral bacteria or its components to the lung. A recent observational study in non-smoking subjects showed that lung volumes and flow rates were significantly reduced by 71-185 ml for severe gingivitis regardless of the adjustment for potential confounders. The result did not show any confounding by smoking, and the association between gingivitis and lower lung function was not modified by systemic inflammation. The designed interventional trial primarily aims to test the hypothesis that gingivitis reduction by optimized daily oral hygiene, professional tooth cleaning and antibacterial chlorhexidine (CHX)-containing mouth rinse improves lung function in terms of forced vital capacity (FVC) by at least 2%. The secondary objective will test the hypothesis that gingivitis reduction improves forced expiratory volume in 1 s (FEV1) and forced expiratory flow at 25-75% of the pulmonary volume (FEF25-75) by at least 2%. Furthermore, the influence of the oral microbiome will be taken into account.
The study has to include 120 non-smoking subjects aged between 18 and 30 years with biofilm-induced gingivitis. The chosen "waiting control group design" will compare the immediate intervention group with the delayed intervention group, which serves as a control group. Dental and gingival status, lung function and oral microbiome will be recorded. The intensified preventive intervention-professional tooth cleaning, one-stage full-mouth disinfection with CHX and safeguarding an optimal daily oral hygiene by each subject-cannot be blinded, but the outcome measurement in terms of lung function tests is blind.
This proposed multidisciplinary study has several strengths. Only one previous intervention study with patients with severe periodontitis (mostly smokers) has been performed. It is novel to include non-smoking subjects with mild and potentially reversible oral inflammation. Furthermore, this research is innovative, because it includes evidence-based interventions for gingivitis reduction, standardized measures of the outcome on lung function and oral microbiome and combines expertise from dentistry, lung physiology, oral microbiology and epidemiology/statistical modelling.
German Clinical Trial Register DRKS00028176. Registered on February 2022.
牙周病和肺功能损害与低度全身或局部炎症有关，可能是牙龈/牙周炎症通过全身炎症或口腔细菌或其成分转移到肺部而引发肺功能下降。最近一项针对不吸烟人群的观察性研究表明，无论是否调整潜在混杂因素，严重牙龈炎会使肺容积和流量分别减少 71-185ml。该结果未显示吸烟的混杂影响，并且牙龈炎与较低的肺功能之间的关联不受全身炎症的影响。这项设计的干预试验主要旨在检验以下假设：通过优化每日口腔卫生、专业洁牙和含抗菌剂洗必泰（CHX）的漱口水来减少牙龈炎，可以使用力肺活量（FVC）至少增加 2%，从而改善肺功能。次要目标将检验以下假设：减少牙龈炎可以使 1 秒用力呼气量（FEV1）和用力呼气量在 25-75%肺容积时的流量（FEF25-75）至少增加 2%。此外，还将考虑口腔微生物组的影响。
该研究必须纳入 120 名年龄在 18 至 30 岁之间、患有生物膜诱导性牙龈炎的不吸烟受试者。选择的“等待对照设计”将比较即时干预组和延迟干预组，后者作为对照组。将记录牙齿和牙龈状况、肺功能和口腔微生物组。强化预防干预-专业洁牙、一次全口消毒用 CHX 和每位受试者保障最佳每日口腔卫生-无法设盲，但肺功能测试的结果测量是盲法的。
这项拟议的多学科研究有几个优势。之前仅对患有严重牙周炎（大多为吸烟者）的患者进行了一项干预研究。纳入轻度和潜在可逆转口腔炎症的不吸烟受试者是新颖的。此外，这项研究具有创新性，因为它包括减少牙龈炎的循证干预措施、标准化的肺功能和口腔微生物组的结果测量，并结合了牙科、肺生理学、口腔微生物学和流行病学/统计建模方面的专业知识。
德国临床试验注册处 DRKS00028176。于 2022 年 2 月注册。
