Minimally Invasive Root Canal Treatment With Active Disinfection on Single Rooted Teeth With Periapical Lesions: A Preliminary Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- radiographic healing based on the periapical index score by Ørstavik et al. 1986
研究概览
简要总结
A novel form of root canal treatment RCT, referred as minimally invasive endodontics MIE, has emerged recently to adopt a unique approach that emphasize reducing tooth structural changes post-treatment (32). MIE seeks to maintain as much of the tooth's healthy coronal, cervical, and radicular anatomy as practical. Access opening, root canal cleaning and shaping, as well as surgical endodontics are all potential areas where MIE can be applied in endodontic therapy (34,36). Technological and technical progress, based on new tools, files and devices, are now allowing the simplification of this approach.
In the context of endodontics, the question may be whether conventional therapeutic approaches are minimally invasive enough (32,34), or whether a less invasive approach is required. This preliminary clinical study examined radiographically a minimally invasive shaping protocol combined with heated multi-sonic based irrigation to achieve disinfection with the removal of the least amount of dentin from the root's hard tissue during root canal shaping, compared to conventionally instrumented root canals, by focusing on the following aspects:
- The change in the area of the periapical lesion (measured in square millimeters) between T0, T3, T6 and T9
- The speed of repair of healed/healing periapical lesions (absolute speed of shrinkage and relative speed of shrinkage).
In addition, this study evaluated the association between radiographic outcomes and the type of endodontic treatment. Results obtained concerning the mentioned factors were compared across both techniques as well as the available ex-vivo and in vivo studies present in the literature. With the objective of cleaning and disinfecting the root canals as a complex while conserving root integrity, further efforts, to adopt such technique in posterior teeth where the mastication force and stress are at their most, could be done to set guidelines for an effective and more conservative root canal therapy.
详细描述
Microorganisms are the primary cause of pulp and periapical disorders (1). The key objective of endodontic therapy is to prevent or to heal apical periodontitis by eliminating inflamed and/or infected pulpal tissues and establishing aseptic intraradicular conditions conductive to periradicular healing (2). This goal is achieved by performing a chemo-mechanical debridement of the root canal system all while preserving the tooth's structural integrity for successful function (3,4).
Root canal instrumentation is primarily done to optimize irrigation and cleaning, particularly in the apical region, and to facilitate an hermetic obturation (5,6). However, mechanical instrumentation is linked with multiple drawbacks including the production of dentin debris and smear layer, the occurrence of iatrogenic errors, root structure weakening, and apical crack formation (7). It was also demonstrated that endodontic files are unable to touch the whole surface of the root canal walls due to the complexity of the root canal anatomy; affecting the total cleaning and the final prognosis (8). Accordingly, a variety of techniques and instruments can be used to render this step minimally invasive (9), as well as to improve the penetration of irrigants into the anatomical complexities (10,11). Minimally invasive endodontics MIE involves minimum intervention using smaller size and taper rotating files in combination with more effective irrigation protocols (12).
Ultrasonic activation of intracanal heated sodium hypochlorite NaOCl as a final irrigation protocol following root canal preparation showed superior bacterial reduction compared to canal preparation and NaOCl activation alone (13). Acoustic streaming and cavitation of heated irrigant are thought to be the working mechanisms (14,15). Recent in vitro studies have argued whether such irrigation protocols could be suitable to disinfect non-instrumented and/ or minimally tapered root canals (6,13,16).
Until now, no randomized clinical trials (RCTs) evaluated the in vivo efficacy of this protocol in un-instrumented canals. In the absence of sufficient models for clinical outcomes, only direct clinical studies evaluating both apical bone fill and tooth function/survival will offer compelling evidence regarding the efficacy of canal disinfection (4). Therefore, the aim of this preliminary randomized clinical trial was to evaluate radiographically the healing of periapical lesions on single rooted teeth following a non-instrumentation technique using ultrasonic activation with intracanal heating of sodium hypochlorite (IHAN) compared to rotary canal instrumentation and ultrasonic activation with heating of NaOCl (R-IHAN).
- Sample size: To determine the sample size, a power analysis for repeated-measures ANOVA (within-subjects factor with 4 measurements) was conducted using G*Power software 3.1.9.7 for Windows (Heinrich Heine, Universitat Düsseldorf, Düsseldorf, Germany); a power of 0.8, an alpha level of 0.05 were considered, and an effect size of 0.35 was calculated based on a previous study conducted by van der Borden et al (34). The minimum sample size required is 13 periapical lesions per group (26 in total). In order to account for losses to follow-up, an attrition rate of 20% was added, which results in a minimum total sample size of 32 (16 per group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients aging from 18 to 40 years old without any known allergic reactions or systemic diseases.
- •Mature necrotic single rooted teeth with a single canal.
- •Fully formed intact root apices.
- •Root canals in which stainless steel Kfile size 15 (Maillefer, Ballaigues, Switzerland) can passively reach the WL.
- •Root canals in which the chosen ultrasonic tip size 20/0.2 reaches the WL minus 3 to 4 mm (Figure 3) and the extra fine heat carrier tip (taper 4%) reaches the WL minus 4 to 5 mm.
- •Estimated working length 20-23 mm
- •Absence of canal calcifications.
- •Absence of root fracture and/or resorption.
- •Teeth with pre-operative periapical radiolucency and PAI score ≥3 according to the classification of Ørstavik et al. 1986.
排除标准
- •Roots with broken or immature open apices.
- •Roots presenting internal, external, or apical resorption.
- •Teeth with previous root canal treatment
- •Teeth with retracted or calcified canals.
- •Teeth with two canals or any other anatomic variations.
- •Extensively restored and prepared teeth.
- •Teeth invaded by caries affecting the roots.
- •Root length less than 16 mm.
- •Abnormal mobility of the tooth.
- •Patients with chronic generalized periodontitis
- •Pregnant patients
- •Patients younger than 18 years old
结局指标
主要结局
radiographic healing based on the periapical index score by Ørstavik et al. 1986
时间窗: 9 months
Treatment outcome scores with PAI were adjusted to reflect clinical success (PAI1 and PAI2 at follow-up), uncertain (PAI3 at follow-up for initial PAI4,5) and failure (persisting PAI3 and any PAI4 or PAI5 at follow-up). Failure was also recorded if the patient did not appear at any follow up recalls, a tooth had been extracted, or had evidence of a sinus tract involving the periapical area at recall.
radiographic healing based of the area percentage change of lesions
时间窗: 9 months
the treatment outcome was presented in four categories: undetected lesion, reduction, enlargement, or unchanged. Reduction and enlargement of the radiolucency were determined only when the change in size of radiolucency was 20% or more. An unchanged lesion was defined as a lesion change less than 20%.
次要结局
未报告次要终点