Sopravvivenza e Healing Rate di Due Tecniche di Otturazione Canalare: Studio Clinico Randomizzato
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Survival rate
研究概览
简要总结
This randomized clinical study analysed the clinical use of a new bioceramic premixed CaSi-containing sealer in association with a warm carrier-based technique or a traditional epoxy resin based sealer.
Methodology: Healthy patients requiring root canal treatments were enrolled. Periapical X-rays were taken preoperatively, after root canal filling and after 1, 6, and 12 and 24 months. Two evaluators assessed the Periapical Index (PAI) and the sealer extrusion. The healing rate and survival rate were also evaluated. Barnard test was used to assess the relationship of each potential prognostic factor with periapical index (PAI) at 12-month follow-up. The significance level was set at 0.05.
详细描述
The study was designed in january 2023 as a prospective randomized clinical study. No major modifications were made to the study design after its initial conception. The patients were treated in the Endodontic Clinical Section-Dental Clinic, University of Bologna, by a pool of postgraduate master operators in accordance with standardized protocols and under the strict supervision of the experienced tutors of the master. All the operators, before the study started, were adequately instructed and trained in sealer application and obturation technique. The study was approved by the ethical committee (597-2022-SPER-AUSLBO).
The study adhered to the principles of the Declaration of Helsinki, as modified in 2013. The clinical staff provided written and verbal information to patients before enrolment.
All patients provided a signed informed consent to accept the treatment plan and to follow the hygiene program. The study was designed in compliance with the STROBE checklist and the guidelines published by Dodson in 2007.
Primary Root Canal Treatment Nerve block anaesthesia (1.7 mL, mepivacaine chloridrate, Scandonest 3%, Septodont, St.-Maur-des-Fosses, France) and local anaesthesia (1.8 mL mepivacaine chloridrate, Scandonest 2% with 1:100,000 adrenaline, Septodont, St.-Maur-des-Fosses, France) were performed. The total duration of each endodontic session was 60 to 90 min. Dental dam isolation was positioned on the affected tooth. A straight-line access was performed with a diamond bur mounted on high-speed water-cooled handpieces (Cefla, Imola, Italy). A preoperative working length was estimated using periapical radiographs. The crown-down technique was used. Gates-Glidden burs #2 and #3 were utilised when necessary, only in the coronal third. NiTi instruments were used to shape the canals in the coronal, medium, and apical third (Rotate, VDW, Munchen, Germany). An electronic apex locator (Root ZX, Morita, Osaka, Japan) with K-file #10 was used to determine the working length during the entire clinical procedure. Intra-oral periapical X-rays were performed to confirm the working length during the root canal instrumentation. Each root canal was shaped in the apical third with an apical diameter of #25.04 at least.
Irrigation was performed after the use of each instrument with a total of 5 mL of 5% NaOCl solution (Niclor 5, OGNA, Muggiò, Italy).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75 years
- •Healthy status (ASA 1 or 2)
- •At least one tooth affected by endodontic pathology (pulpitis, pulp necrosis, re-exacerbated lesions with a previous root canal treatment) (b)
排除标准
- •Teeth with less than 2 walls of crown structural integrity
- •Teeth used as abutments for fixed rehabilitation
- •Presence of active periodontal disease (PPD > 4 mm, general BoP > 25% of the sites)
- •Wide apexes (>40 diameters) or absence of radiographic pulp chamber
- •Any systemic pathology that could compromise bone healing or the immune response (i.e., diabetes)
- •Pregnancy or breastfeeding
- •Heavy smoking (>15 cigarettes/day)
- •Exposure to radiation therapy focused on the head and neck region and malignant disease directly involving the jaws.
- •Lack of occlusal contacts
结局指标
主要结局
Survival rate
时间窗: 12 months, 24 months
number of teeth still functional at the endline
Healing rate
时间窗: 3 months, 6 months 12 months, 24 months
number of teeth with no periapical lesion at the endline using periapical index (PAI)
次要结局
- Post operative pain(at the moment of root canal filling, at 1 day, 7 days, 28 days)
研究者
Fausto Zamparini
Researcher
University of Bologna