Shah Aaqib, Pv Amritha, Sharma Sidhartha, Kumar Vijay, Chawla Amrita, Logani Ajay
Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.
Int Endod J. 2025 May;58(5):715-726. doi: 10.1111/iej.14205. Epub 2025 Jan 31.
To compare the outcome of full and deep pulpotomy performed in mature permanent teeth with extremely deep carious lesion and symptomatic irreversible pulpitis.
This parallel-group, double-blind, non-inferiority randomized controlled trial was conducted after ethical clearance. Patients with mature permanent teeth with extremely deep carious lesion and diagnosis of symptomatic irreversible pulpitis were recruited. Teeth were randomly allocated to two study groups, i.e. Group I: full pulpotomy (excision of pulp tissue up to the level of root canal orifices) and Group II: deep pulpotomy (excision of radicular pulp tissue 2-3 mm apical to root canal orifices). Haemostasis was achieved using cotton pellet moistened with 2.5% NaOCl for up to 10 min. Mineral trioxide aggregate was used as a pulp capping agent and teeth were restored in the same visit with resin composite. Outcome assessment was performed at 12-month follow-up based on clinical and radiographic evaluation. The success rate was determined by intention-to-treat (ITT) and per-protocol (PP) analysis. Two sample t-tests were used to compare the time taken to achieve haemostasis and determine its association with treatment outcome.
A total of sixty teeth received treatment in both study groups. The bleeding time was significantly more in Group I (6.13 ± 1.59 min) compared to group II (5.23 ± 1.22 min) (p < .0171). The recall rate was 86.6% at study end point when fifty-two teeth were analysed at 12-month follow up. The success rate was 88.46% and 92.30% for per protocol analysis and 76.67 and 80% for ITT analysis for Group I and Group II, respectively, without any statistically significant difference (p = .610). The absolute risk difference between each treatment was within the 10% non-inferiority limit. There was no statistically significant association between time taken to achieve haemostasis and treatment outcome in both study groups.
There was no significant difference between full and deep pulpotomy techniques, with respect to achievement of haemostasis and treatment outcome for management of teeth with extremely deep caries and irreversible pulpitis.
比较在患有极深龋损和有症状的不可逆性牙髓炎的成熟恒牙上进行完全性和深部牙髓切断术的效果。
本平行组、双盲、非劣效性随机对照试验在获得伦理批准后进行。招募患有极深龋损且诊断为有症状的不可逆性牙髓炎的成熟恒牙患者。牙齿被随机分配到两个研究组，即：第一组：完全性牙髓切断术（将牙髓组织切除至根管口水平）和第二组：深部牙髓切断术（将根髓组织切除至根管口根尖2 - 3毫米处）。使用用2.5%次氯酸钠浸湿的棉球止血长达10分钟。使用三氧化矿物凝聚体作为牙髓盖髓剂，并在同一次就诊时用树脂复合材料修复牙齿。在12个月随访时基于临床和影像学评估进行结果评估。成功率通过意向性分析（ITT）和符合方案分析（PP）来确定。使用两样本t检验比较止血所需时间并确定其与治疗结果的关联。
两个研究组共有60颗牙齿接受了治疗。与第二组（5.23±1.22分钟）相比，第一组（6.13±1.59分钟）的出血时间明显更长（p <.0171）。在研究终点，当在12个月随访时分析52颗牙齿时，召回率为86.6%。第一组和第二组的符合方案分析成功率分别为88.46%和92.30%，意向性分析成功率分别为76.67%和80%，无任何统计学显著差异（p = 0.610）。每种治疗之间的绝对风险差异在10%的非劣效性界限内。两个研究组中止血所需时间与治疗结果之间均无统计学显著关联。
在极深龋齿和不可逆性牙髓炎的牙齿治疗中，就止血效果和治疗结果而言，完全性和深部牙髓切断术技术之间没有显著差异。
