Assistant Professor and Director of the Evidence-Based Practice Unit, Ajman University College of Dentistry, Ajman City, UAE.
Visiting Research Professor, Department of Reconstructive Dentistry and Gerodontology, School of Dental Medicine, University of Bern, Bern, Switzerland.
Evid Based Dent. 2023 Jun;24(2):54-56. doi: 10.1038/s41432-023-00878-4. Epub 2023 May 15.
A systematic appraisal and statistical aggregation of primary studies.
Scopus/ELSEVIER, PubMed/MEDLINE, Clarivate Analytics' Web of Science (i.e., Web of Science Core Collection-WoS, Korean Journal Database-KJD, Russian Science Citation Index-RSCI, SciELO Citation Index-SCIELO), and Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Library.The complementary searches consisted of OpenGrey, Google Scholar (first 100 returns), Networked Digital Library of Theses and Dissertations, Open Access Theses and Dissertations, DART-Europe E-theses Portal-DEEP, Opening access to UK theses-EThOS.
Human clinical trials studies in English language with at least 10 patients with mature or immature permanent teeth with pulpitis characterized by spontaneous pain in each arm (i.e., root canal treatment [RCT] and pulpotomy) at the end of the study, comparing the patient- (Primary: survival, pain, tenderness, swelling assessed by clinical history, clinical examination, and pain scales; Secondary: tooth function, need for further intervention, adverse effects; OHRQoL using a validated questionnaire) and clinical-reported outcomes (Primary: emerging apical radiolucency as per intraoral periapical radiograph or limited FOV CBCT scan; Secondary: radiological evidence of continued root formation and presence of sinus tract).
Two independent review authors conducted study selection, data extraction and risk of bias (RoB) assessment and a third reviewer was consulted for solving disagreements. When insufficient or absent information, the corresponding author was reached out to for further explanation. The Cochrane RoB tool for randomized trials (RoB 2.0) was evaluated the quality of studies.The meta-analysis was performed on a fixed-effect model to estimate pooled effect size such as odds ratio (OR) and 95% confidence intervals (CIs) were performed using the R software. The quality of evidence assessed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach (GRADEpro GDT: GRADEpro Guideline Development Tool [software], McMaster University, 2015).
Five primary studies were included. Four studies referred to a multicentre trial assessing postoperative pain and long-term success rate after pulpotomy compared with one-visit RCT in 407 mature molars. The other study was a multicentre trial assessing postoperative pain in 550 mature molars treated with pulpotomy and pulp capping with the calcium-enriched mixture (CEM), pulpotomy and pulp capping with mineral trioxide aggregate (MTA) and one-visit RCT. Both trials primarily reported first molars from young adults. When looking at the results of postoperative pain, all the trials included had a low RoB. However, when evaluating the clinical and radiographic outcomes of the included reports, it was determined that there was a high RoB. The meta-analysis found that the likelihood of experiencing pain (i.e., mild, moderate, or severe) at the 7th postoperative day was not affected by the type of intervention (OR = 0.99, 95% CI 0.63-1.55, I = 0%).The study design, risk of bias, inconsistency, indirectness, imprecision, and publication bias domains were used to grade the quality of evidence for postoperative pain between RCT and full pulpotomy, resulting in a 'High' grade. In the first year, clinical success was high for both interventions, with a rate of 98%. However, the success rate declined over time, with pulpotomy showing a 78.1% success rate and RCT showing a 75.3% success rate at the 5-year follow up.
This systematic review was limited by the inclusion of only two trials, indicating a lack of sufficient evidence to draw definitive conclusions. Nonetheless, the available clinical data suggests that patient-reported pain outcomes do not differ significantly between RCT and pulpotomy at Day 7 postoperatively, and that the long-term clinical success rate of both treatments is comparable, as demonstrated by a single randomized control trial. However, to establish a more robust evidence base, additional high-quality randomized clinical trials, conducted by diverse research groups, are needed in this field. In conclusion, this review underscores the insufficiency of current evidence to draw solid recommendations.
对原始研究进行系统评估和统计综合。
Scopus/ ELSEVIER、PubMed/ MEDLINE、Clarivate Analytics 的 Web of Science（即 Web of Science 核心合集-WoS、韩国期刊数据库-KJD、俄罗斯科学引文索引-RSCI、SciELO 引文索引-SCIELO）和 Cochrane 中央对照试验注册中心（CENTRAL）通过 Cochrane 图书馆。补充搜索包括 OpenGrey、Google Scholar（前 100 个结果）、数字论文网络、开放获取论文和 Dissertations、DART-Europe E-theses Portal-DEEP、开放获取英国论文-EThOS。
以英语进行的人类临床试验研究，每个手臂（即根管治疗 [RCT] 和牙髓切断术）均有至少 10 名成熟或未成熟恒牙的牙髓炎患者，在研究结束时比较患者（主要：生存、疼痛、压痛、通过临床病史、临床检查和疼痛量表评估的肿胀；次要：牙齿功能、需要进一步干预、不良影响；使用经过验证的问卷评估 OHRQoL）和临床报告的结果（主要：根据口腔根尖 X 线片或有限 FOV CBCT 扫描评估新出现的根尖放射性透明区；次要：继续根形成和窦道存在的放射学证据）。
两名独立的审查员进行了研究选择、数据提取和风险偏倚（RoB）评估，第三名审查员在解决分歧时进行了咨询。当信息不足或缺失时，联系相应的作者以获得进一步的解释。使用 R 软件对 Cochrane 随机试验 RoB 工具（RoB 2.0）评估了研究质量。对固定效应模型进行了荟萃分析，以估计汇总效应大小，例如比值比（OR）和 95%置信区间（CI）使用。使用 Grading of Recommendations，Assessment，Development and Evaluations（GRADE）方法（GRADEpro GDT：GRADEpro 指南开发工具 [软件]，麦克马斯特大学，2015 年）评估证据质量。
纳入了五项主要研究。四项研究涉及一项多中心试验，评估牙髓切断术后疼痛和长期成功率，与一项 407 颗成熟磨牙的一次性 RCT 相比。另一项研究是一项多中心试验，评估了 550 颗成熟磨牙在牙髓切断术和钙富集混合物（CEM）盖髓、牙髓切断术和三氧化矿物聚合体（MTA）盖髓以及一次性 RCT 治疗后的术后疼痛。这两项试验主要报告了年轻成年人的第一磨牙。当观察术后疼痛的结果时，所有试验的 RoB 均较低。然而，当评估包括报告的临床和放射学结果时，确定 RoB 较高。荟萃分析发现，第 7 天出现疼痛（即轻度、中度或重度）的可能性不受干预类型的影响（OR=0.99，95%CI 0.63-1.55，I=0%）。研究设计、风险偏倚、不一致性、间接性、不精确性和发表偏倚域用于评估 RCT 和全牙髓切断术之间的术后疼痛证据质量，导致“高”等级。在第一年，两种干预措施的临床成功率均较高，为 98%。然而，随着时间的推移，成功率下降，牙髓切断术 5 年随访时的成功率为 78.1%，而 RCT 为 75.3%。
本系统评价受到仅纳入两项试验的限制，表明缺乏足够的证据来得出明确的结论。尽管如此，可用的临床数据表明，患者报告的疼痛结果在第 7 天术后 RCT 和牙髓切断术之间没有显著差异，并且两种治疗方法的长期临床成功率相当，这是一项单中心随机对照试验的结果。然而，为了建立更强大的证据基础，需要在该领域开展更多由不同研究小组进行的高质量随机临床试验。总之，本综述强调了目前证据不足以得出可靠建议。
