Sareen Shubham, Brar Prabhleen Kaur, Gupta Shipra, Goyal Lata
Oral Health Sciences Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India.
All India Institute of Medical Sciences, Bathinda, Punjab, India.
Evid Based Dent. 2025 Mar;26(1):6-7. doi: 10.1038/s41432-025-01109-8. Epub 2025 Jan 31.
The study is a prospective, double-blinded randomised control trial that compares the mineral trioxide aggregate (MTA) and Biodentine as the pulp space barrier material after induction of a periapical blood clot by over-instrumentation for endodontic regeneration in single-rooted mature permanent anterior tooth (closed apex) with apical periodontitis (periapical pathology of more than 3 mm) and having necrosed pulp. A total of 36 patients were included in the study and after randomisation were allocated equally to both the groups out of which 31 patients returned for follow-up over an 18-month period. The treatment protocol consisted of two separate appointments. At the first appointment, a standardised and custom-made radiographic guide was prepared for each patient to ensure uniformity and repeatability of the radiographs at subsequent follow-up visits. This was followed by access to the pulp chamber and biomechanical preparation of the single canal up to master apical file size. The irrigant used in each case was 1.5% sodium hypochlorite and also calcium hydroxide intracanal medicament was placed during this visit. The interval between the two appointments was not fixed and depended on the patient's symptoms following the first visit; however, the maximum allowable time frame was set at 3 weeks. During the second visit after irrigation with 17% ethylenediaminetetraacetic acid (EDTA) over instrumentation was done to induce bleeding that was allowed to fill the canal. The clot was stabilised by collagen plug and the pulp space sealer (either MTA or Biodentine) was placed below the cementoenamel junction following which composite restoration was done. The radiographs were taken before the treatment, after both the appointments and at 6, 9, 12 and 18 months subsequently by a single experienced examiner. Pre-operatively, a periapical index score (PAI) was given to each case and the sensibility test was performed at 6, 12, 18 months postoperatively using an electric pulp tester (EPT).
Participants were recruited from the Department of Endodontics outpatient clinic. The patients were aged between 10-35 years and had no systemic conditions. For inclusion in the study, participants were required to have mature anterior tooth (single root canal) with closed apex associated with apical periodontitis and necrotic pulp having periapical radiolucency of more than 3 mm on the radiograph. Patients suffering from periodontitis (ensured by periodontal probing) and those having developmental anomalies of the teeth were excluded from the study.
The normalcy of the data was assessed by Shapiro-Wilk test. Continuous data was analysed by Mann Whitney U test and the categorical data was analysed by Chi-square test and Fisher's exact test. With the level of significance set at 0.05.
Firstly, the author presented the overall healing of the periapical lesion from Fisher's exact test, which showed that after 18 months, out of 31 patients, 21 cases (67.7%) had completely healed and 10 cases (32.3%) showed signs of healing and no case remained unhealed. The difference between the Biodentine and MTA was non-significant as derived from the Chi-square test for comparison of postoperative lesion sizes score at 18 months postoperatively. Secondly, based on EPT, the author presented the regain of tooth sensibility from Fisher's exact test which shows that out of 31 cases, 22 (71%) showed a positive response to EPT and 9 cases (29%) showed no response. Again, the difference between Biodentine and MTA was non-significant.
Both Biodentine and MTA when used as pulp space barrier in regenerative endodontic procedures showed promising results. In both groups significant reduction in the size of periapical radiolucency was noted along with resolution of patient's symptoms. There was also significant regain in the tooth sensibility postoperatively. As there was no significant difference between the two in the treatment outcomes, both of these biomaterials can be used to treat apical periodontitis in mature permanent tooth as an alternative to conventional endodontic treatment in which the vitality of tooth is lost.
本研究为前瞻性、双盲随机对照试验，比较在单根成熟恒牙（根尖封闭）伴根尖周炎（根尖病变超过3mm）且牙髓坏死的情况下，采用过度预备根管诱导根尖周血凝块后，矿物三氧化物凝聚体（MTA）和生物陶瓷（Biodentine）作为牙髓腔阻隔材料用于牙髓再生的效果。本研究共纳入36例患者，随机分组后两组各18例，其中31例患者在18个月的时间里进行了随访。治疗方案包括两次独立的就诊。第一次就诊时，为每位患者制作标准化定制的放射学导板，以确保后续随访时X线片的一致性和可重复性。随后打开髓腔，对单根管进行生物力学预备直至主尖锉尺寸。每例使用的冲洗液为1.5%次氯酸钠，此次就诊时还在根管内放置了氢氧化钙药物。两次就诊之间的间隔不固定，取决于患者首次就诊后的症状；然而，最长允许时间设定为3周。第二次就诊时，用17%乙二胺四乙酸（EDTA）冲洗后进行过度预备以诱导出血，使血液充满根管。用胶原塞稳定血凝块，并在牙骨质釉质界下方放置牙髓腔封闭剂（MTA或生物陶瓷），随后进行复合树脂修复。在治疗前、两次就诊后以及随后的6、9、12和18个月由同一位经验丰富的检查者拍摄X线片。术前，对每例患者进行根尖指数评分（PAI），并在术后6、12、18个月使用牙髓电活力测试仪（EPT）进行牙髓敏感性测试。
研究对象来自牙髓病科门诊。患者年龄在10 - 35岁之间，无全身系统性疾病。纳入本研究的参与者需有成熟的前牙（单根管），根尖封闭，伴有根尖周炎，牙髓坏死，X线片显示根尖周透射影超过3mm。患有牙周炎（通过牙周探诊确定）和牙齿发育异常的患者被排除在研究之外。
采用Shapiro-Wilk检验评估数据的正态性。连续数据采用Mann-Whitney U检验分析，分类数据采用卡方检验和Fisher精确检验分析。显著性水平设定为0.05。
首先，作者通过Fisher精确检验展示了根尖周病变的总体愈合情况，结果显示，18个月后，31例患者中，21例（67.7%）完全愈合，10例（32.3%）有愈合迹象，无病例未愈合。通过卡方检验比较术后18个月病变大小评分，生物陶瓷和MTA之间的差异无统计学意义。其次，基于EPT，作者通过Fisher精确检验展示了牙齿感觉功能的恢复情况，结果显示，31例患者中，22例（71%）对EPT呈阳性反应，9例（29%）无反应。同样，生物陶瓷和MTA之间的差异无统计学意义。
在牙髓再生治疗中，生物陶瓷和MTA作为牙髓腔阻隔材料均显示出良好的效果。两组根尖周透射影大小均显著减小，患者症状得到缓解。术后牙齿感觉功能也显著恢复。由于两种材料在治疗效果上无显著差异，这两种生物材料均可用于治疗成熟恒牙根尖周炎，作为导致牙齿丧失活力的传统牙髓治疗的替代方法。
