Therapeutic Irrigant Procedures for Treating Apical Periodontitis (TIPTAP): A triple-blinded parallel-group randomized controlled phase I/II trial

IF 7.1 1区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE
Satnam Singh Virdee, Nasir Zeeshan Bashir, Melissa M. Grant, Paul R. Cooper, Phillip L. Tomson
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引用次数: 0

Abstract

Background

Solubilized endogenous dentine extracellular matrix components (dECMs) are potent mediators in pulp regeneration and could potentially promote similar healing effects in diseased periradicular tissues by upregulating local mesenchymal stem cell-derived regenerative events.

Aims

(1) Determine if endodontic treatment outcomes with irrigation regimes promoting dECM release (17% ethylenediaminetetraacetic acid [EDTA]) are equivalent to conventional regimes (5.25% sodium hypochlorite [NaOCl]) in mature permanent teeth with asymptomatic apical periodontitis. (2) Explore changes in pain scores, expressions of periradicular tissue fluid (PTF)-derived inflammatory mediators, and volumtric changes in lesion size between the different irrigant regimes.

Methods

Forty single-rooted teeth, from 37 healthy adults, were block randomized into parallel groups of irrigation with either 17% EDTA, optimized for dECM solubilization, or 5.25% NaOCl (n = 20). All other aspects of the endodontic protocol were standardized over two visits with 14 days of calcium hydroxide intracanal medicament. Patient-reported pain scores were recorded at six hours and then daily for one week post-instrumentation and post-obturation. PTF samples were collected pre-instrumentation and pre-obturation, where analyte profiles (pg/TPC) were determined using an O-link Target-48 cytokine array. Treatment outcomes were clinically and radiographically assessed with cone beam computed tomography at 1 year using dichotomous criteria (favourable/unfavourable) based on volumetric change in lesion size. Participants, operators and assessors were blinded, and per-protocol analyses were conducted using binary logistic regression models with initial alpha values for statistical comparisons set at p < .05.

Results

A 90% recall rate was achieved at one year (NaOCl: 19; EDTA: 17). Favourable outcomes were observed in 89.5% of treatments using NaOCl and 94.1% of treatments using EDTA irrigation, with median lesion volume reductions of 92.5% (IQR: 67.33–99.13) and 95.84% (IQR: 78.81–100), respectively, (p > .05). Odds of unfavourable periradicular healing with EDTA irrigation were 0.53 [95% CI: 0.04–6.44; p > .05]. No serious adverse effects or atypical pain patterns were reported, although two acute exacerbations occurred post-instrumentation with NaOCl irrigation (p > .05). Target-48 panels consistently detected 15 inflammatory analytes in both groups (CCL-2, -3, -4; CSF-1; CXCL-8; HGF; IL-1β, -6, -18; MMP-1, -12; OLR-1; OSM; TNFSF-10; VEGF-A), all of which reduced pre-obturation. At this stage, IL-6 and -18 were significantly more abundant in the intervention group (p < .05).

Conclusions

Therapeutic irrigant regimes promoting dECM solubilization resulted in one-year treatment outcomes equivalent to conventional irrigant protocols with no serious adverse effects reported.

Abstract Image

治疗根尖牙周炎的治疗性冲洗程序(TIPTAP):一项三盲平行组随机对照I/II期试验。
背景:溶解内源性牙本质细胞外基质成分(dECMs)是牙髓再生的有效介质,可能通过上调局部间充质干细胞来源的再生事件,促进患病根周组织类似的愈合效果。目的:(1)确定对于无症状根尖牙炎的成熟恒牙,采用促进dECM释放(17%乙二胺四乙酸[EDTA])的灌洗剂治疗效果是否与常规灌洗剂(5.25%次氯酸钠[NaOCl])治疗效果相当。(2)探讨疼痛评分、神经根周围组织液(PTF)衍生炎症介质的表达以及不同灌洗方式下病变大小的体积变化。方法:选取37例健康成人的40颗单根牙,随机分为两组(n = 20),分别用17% EDTA和5.25% NaOCl进行冲洗。所有其他方面的根管治疗方案都是标准化的,在两次访问中使用了14天的氢氧化钙管内药物。记录患者报告的疼痛评分,每6小时记录一次,然后每天记录一次,持续一周。PTF样品在仪器前和封闭前收集,分析物谱(pg/TPC)使用O-link Target-48细胞因子阵列测定。治疗结果在1年内通过锥形束计算机断层扫描使用基于病变体积变化的二分标准(有利/不利)进行临床和放射学评估。参与者、操作人员和评估人员采用盲法,采用二元逻辑回归模型进行协议分析,初始alpha值设置为p进行统计比较。结果:一年后召回率达到90% (NaOCl: 19;EDTA: 17)。89.5%的NaOCl治疗和94.1%的EDTA冲洗治疗效果良好,病灶体积中位数缩小92.5% (IQR: 67.33-99.13)和95.84% (IQR: 78.81-100),差异有统计学意义(p < 0.05)。EDTA冲洗导致根周愈合不良的几率为0.53 [95% CI: 0.04-6.44;[00 .05]。没有严重的不良反应或非典型疼痛模式的报道,尽管使用NaOCl灌洗后发生了两次急性加重(p < 0.05)。Target-48组在两组中均检测到15种炎症分析物(CCL-2, -3, -4;CSF-1;CXCL-8;胶质瘤;Il-1β, -6, -18;金属蛋白酶- 1,-12;OLR-1;OSM;TNFSF-10;VEGF-A),所有这些都减少了预闭孔。在这一阶段,干预组IL-6和-18的含量明显更高(p)。结论:促进dECM溶解的治疗性冲洗方案导致一年的治疗结果与传统冲洗方案相当,没有严重的不良反应报告。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
International endodontic journal
International endodontic journal 医学-牙科与口腔外科
CiteScore
10.20
自引率
28.00%
发文量
195
审稿时长
4-8 weeks
期刊介绍: The International Endodontic Journal is published monthly and strives to publish original articles of the highest quality to disseminate scientific and clinical knowledge; all manuscripts are subjected to peer review. Original scientific articles are published in the areas of biomedical science, applied materials science, bioengineering, epidemiology and social science relevant to endodontic disease and its management, and to the restoration of root-treated teeth. In addition, review articles, reports of clinical cases, book reviews, summaries and abstracts of scientific meetings and news items are accepted. The International Endodontic Journal is essential reading for general dental practitioners, specialist endodontists, research, scientists and dental teachers.
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