基于ClinicalTrials.gov分析光动力治疗口腔疾病临床研究注册项目的特征

doi:10.13701/j.cnki.kqyxyj.2025.04.012

摘要/Abstract

摘要： 目的: 分析ClinicalTrials.gov数据库注册的光动力疗法(photodynamic therapy,PDT)治疗口腔疾病临床研究的特征。方法: 检索并搜集ClinicalTrials.gov数据库所有注册的PDT治疗口腔疾病的临床研究,检索时限为从ClinicalTrials.gov建库至2023年12月31日。对纳入研究PDT治疗口腔疾病临床研究的注册题目、注册状态、注册时间、样本量、组长单位、研究实施地点、经费类型、疾病类型、结局指标、研究类型及设计、随机方法、盲法、研究中心数量、光源、光敏剂等信息分别进行汇总分析。结果: 共纳入临床研究133项,口腔疾病类型主要为牙周炎(36.09%)、牙龈炎(15.79%)、口臭(6.77%)、牙髓根尖周病(6.77%)、种植体周围炎(5.26%)、龋病(5.26%)、口腔癌(4.51%)、光化唇炎(3.76%)、口腔白斑(3.76%)、口腔扁平苔藓(3.76%)等。参与实施PDT治疗口腔疾病临床研究的组长单位地域分布集中在巴西(38.35%)、美国(9.77%)、中国(6.77%)、芬兰(5.26%)和沙特阿拉伯(4.51%)等5个国家,占总数的64.66%。所有临床研究均为干预性研究,研究设计为随机对照临床试验(randomised controlled trial,RCT)的108项(81.20%),RCT中应用盲法的研究90项(83.33%)。样本量最大350,最小2,中位数为40;单中心的研究占比达93.98%。激光及发光二极管光源在PDT治疗口腔疾病应用较多,以660 nm的红色激光为主;光敏剂主要为亚甲蓝、甲苯胺蓝、5-氨基酮戊酸、吲哚菁绿、姜黄素。结论: 牙周炎、牙龈炎、口臭、牙髓根尖周病、种植体周围炎、龋病、口腔癌、光化唇炎、口腔白斑、口腔扁平苔藓等是PDT治疗口腔疾病临床研究的热点领域。目前PDT治疗口腔疾病的临床研究光敏剂、波长、能量密度、功率密度、结局指标、观测时长的不一致性突出,后期应根据疾病类型及严重程度制定标准治疗方法,以期达到理想的治疗效果。RCT和应用盲法的研究占比较高,研究数量呈波动式上升,但国家间研究数量不均衡性明显,单中心和样本量小的研究占比高,需进一步开展多中心大样本RCT,以推动PDT在口腔疾病治疗的应用。

关键词: 光动力疗法, 口腔疾病, 临床研究, ClinicalTrials.gov

Abstract: Objective: To analyse the characteristics of clinical trials of photodynamic therapy (PDT) for the treatment of oral diseases registered in ClinicalTrials.gov. Methods: All clinical trials of PDT for the treatment of oral diseases in ClinicalTrials.gov were retrieved and collected with a search timeframe from the establishment to 31 December 2023. The registration title, registration status, registration time, sample size, group leader unit, study implementation site, funding type, disease type, outcome, study type and design, randomised method, blinded method, number of study centres, light source, and photosensitiser of the included clinical trials investigating the treatment of oral diseases were summarised and analysed separately. Results: A total of 133 clinical trials were included, and the main types of oral diseases were periodontitis (36.09%), gingivitis (15.79%), halitosis (6.77%), endodontics diseases (6.77%), peri-implantitis (5.26%), dental caries (5.26%), oral cancer (4.51%), actinic lipitis (3.76%), oral leukoplakia (3.76%), and oral lichen planus (3.76%). The geographic distribution of the group leader units involved in the implementation of clinical trials of PDT for oral diseases was concentrated in five countries, including Brazil (38.35%), the United States (9.77%), China (6.77%), Finland (5.26%), and Saudi Arabia (4.51%), which accounted for 64.66% of all the group leader units. All studies were intervention studies, in which 108 studies (81.20%) were randomised controlled trials (RCT) and 90 RCT (83.33%) were blinding. The maximum sample size was 350 and the minimum was 2, with a median of 40; and 93.98% were single-centre studies. Laser and light-emitting diode (LED) light sources were frequently used in PDT for oral diseases, with 660nm red laser being the main one. Photosensitizers mainly included methylene blue, toluidine blue, 5-aminolevulinic acid, indocyanine green, and curcumin. Conclusion: Periodontitis, gingivitis, halitosis, endodontics diseases, peri-implantitis, dental caries, oral cancer, actinic lipitis, oral leukoplakia, oral lichen planus, and so on, are the hot areas of the clinical research of PDT for oral diseases. The inconsistency of photosensitiser, wavelength, energy density, power density, outcome, observation duration in the current clinical trials of photodynamic therapy for oral diseases is prominent, and a standard treatment method needs to be developed to achieve homogeneity of treatment effects. RCT applying the blind method accounted for a high proportion of studies, the overall design quality was high, and the number of studies was fluctuating, but the imbalance in the number of studies between countries was obvious, with a high proportion of single-center and small-sample-size studies, and further multi-centre and large-sample RCT need to be carried out.

Key words: photodynamic therapy, oral diseases, clinical trials, ClinicalTrials.gov

郭锦材, 胡美玲, 张瑞彬, 朱丽雷, 谢辉. 基于ClinicalTrials.gov分析光动力治疗口腔疾病临床研究注册项目的特征[J]. 口腔医学研究, 2025, 41(4): 338-344.

GUO Jincai, HU Meiling, ZHANG Ruibin, ZHU Lilei, XIE Hui. Analysis on Characteristics of Clinical Trial Registries of Photodynamic Therapy for Oral Diseases Based on ClinicalTrialsgov[J]. Journal of Oral Science Research, 2025, 41(4): 338-344.

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