Effect of Different Chelation Protocols on the Healing of Periapical Lesions in Teeth With Chronic Apical Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Periapical Lesion Healing
研究概览
简要总结
The aim of this study is to evaluate the effects of different irrigation protocols using ethylenediaminetetraacetic acid (EDTA) and etidronic acid (HEBP) on periapical lesion healing and postoperative pain in single-rooted, single-canal mandibular anterior and premolar teeth diagnosed with chronic apical periodontitis.
详细描述
Materials and Methods Study Design This study was designed as a randomized clinical trial with three parallel experimental arms and included data obtained from a total of 63 patients.
Randomization and Blinding
Patients were randomly allocated to one of the following three groups:
Irrigation with 2.5% sodium hypochlorite (NaOCl) during canal preparation and 17% ethylenediaminetetraacetic acid (EDTA) as the final irrigant; Irrigation with 2.5% NaOCl during canal preparation and a combination of 2.5% NaOCl and 9% etidronic acid (HEBP) as the final irrigant; Irrigation with a mixture of 2.5% NaOCl and 9% HEBP throughout the entire irrigation protocol.
Randomization was performed using an online randomization tool (www.randomizer.org). Block randomization with a block size of four was applied to ensure an equal 1:1 allocation among the study groups. All endodontic procedures were performed by a single experienced operator. Due to the inherent differences between the irrigation protocols, blinding of the patients, the operator, and the radiographic evaluator was not feasible.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients of both sexes aged 18-60 years, with no systemic diseases, will be screened for inclusion in the study. Strict eligibility criteria will be applied.
- •Eligible patients will present with restorable mandibular single-rooted premolar and anterior teeth, a healthy periodontal status (periodontal pocket depth ≤3 mm), and a clinical diagnosis of chronic apical periodontitis. The diagnosis of chronic apical periodontitis will be based on the absence of clinical symptoms, the presence of pulpal necrosis, negative responses to electric pulp testing and cold testing, and the detection of a radiolucent area in the periapical region on radiographic examination. In addition, included teeth must exhibit a periapical lesion with a Periapical Index (PAI) score of 2 or higher.
排除标准
- •Patients with systemic diseases (such as diabetes mellitus, hypertension, chronic liver disease, or coagulation disorders), those with bone metabolism disorders and/or those using medications that affect bone metabolism (including steroids and bisphosphonates), and pregnant patients will be excluded from the study.
- •In addition, teeth presenting with periodontal pocket depths greater than 3 mm, internal or external root resorption, vertical or horizontal root fractures, a history of previous root canal treatment, the presence of a sinus tract, or intraoral or extraoral abscess associated with the involved tooth, as well as teeth deemed non-restorable, will not be included in the study.
研究组 & 干预措施
Group I: Final irrigation with 2.5% NaOCl and 17% EDTA
After preparation of the access cavity the working length (WL) will be determined using an electronic apex locator (Root ZX [Morita, Tokyo, Japan]) and confirmed radiographically. Following glide path preparation, the root canals will be shaped to the working length using a Resiproc files (VDW, Munich, Germany) in accordance with the manufacturer's instructions, employing the crown-down preparation technique.
During canal preparation, irrigation will be performed with a total of 20 mL of 2.5% NaOCl. After completion of preparation, irrigation will be carried out with 10 mL of distilled water, followed by sequential irrigation with 3 mL of 17% EDTA, 10 mL of distilled water, and 2 mL of 2.5% NaOCl.
干预措施: Final irrigation with 2.5% NaOCl and 17% EDTA (Procedure)
Group II: Final irrigation with 2.5% NaOCl and 9% HEBP
After preparation of the access cavity, the working length (WL) will be determined using an electronic apex locator (Root ZX [Morita, Tokyo, Japan]) and confirmed radiographically. Following glide path preparation, the root canals will be shaped to the working length using a Resiproc files (VDW, Munich, Germany) in accordance with the manufacturer's instructions, employing the crown-down preparation technique.
During canal preparation, irrigation will be performed with a total of 20 mL of 2.5% NaOCl. After completion of preparation, irrigation will be carried out with 10 mL of distilled water, followed by final irrigation with 5 mL of 2.5% NaOCl-9% HEBP.
干预措施: Final irrigation with 2.5% NaOCl and 9% HEBP (Procedure)
Group III: Irrigation with 2.5% NaOCl-9% HEBP during both preparation and final irrigation
After preparation of the access cavity, the working length (WL) will be determined using an electronic apex locator (Root ZX [Morita, Tokyo, Japan]) and confirmed radiographically. Following glide path preparation, the root canals will be shaped to the working length using a Resiproc files (VDW, Munich, Germany) in accordance with the manufacturer's instructions, employing the crown-down preparation technique.
During both canal preparation and final irrigation, a total of 25 mL of 2.5% NaOCl-9% HEBP will be used for irrigation.
干预措施: Irrigation with 2.5% NaOCl-9% HEBP during both preparation and final irrigation (Procedure)
结局指标
主要结局
Periapical Lesion Healing
时间窗: 1 year
Radiographic periapical status assessed using the Periapical Index (PAI) according to Ørstavik et al., with scores ranging from 1 (normal periapical structures) to 5 (severe apical periodontitis), based on the degree of periapical radiolucency. The primary outcome will be periapical lesion healing, evaluated by changes in periapical index (PAI) scores on periapical radiographs taken before treatment and at the 12-month follow-up.
次要结局
未报告次要终点
研究者
Merve Sari
Assistant Professor
Mustafa Kemal University