Effect of Apical Patency on Success of Primary Non-surgical Root Canal Treatment in Non Vital Teeth - a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Change in periapical radiolucency
研究概览
简要总结
Maintaining Apical patency during root canal treatment is a widely followed methodology in modern endodontic treatment protocols. It involves passing of a small #08 or #10 K file through the apical foramen during root canal shaping without widening it. it is done to keep the foramen and apical thirds of root canal free of debris. proponents of the procedure claim it to improve irrigation; provide better tactile feedback; reduce the chances of procedural errors; reduce transportation and reduce pain following root canal procedures. however, there is no clinical trial which specifically evaluates the effect of apical patency on outcome of root canal procedure. hence this study was designed to evaluate the effect of apical patency on outcome of root canal treatment.
详细描述
AIM:
- To assess the role of maintaining Apical Patency on success of primary Non-Surgical Root Canal Treatment (NSRCT) in Non-Vital teeth.
- To evaluate the incidence of post-operative complications such as pain, flare-up etc with and without maintaining apical patency.
Study subjects were recruited from the pool of patients referred for the initial non-surgical root canal treatment to the post graduate department Of Conservative Dentistry & Endodontics at PGIDS, Rohtak (Haryana). Patients requiring Root Canal Treatment following the diagnosis pulpal necrosis in mature mandibular first molar were selected for the study.
Clinical procedure:
Subjects were randomly allocated to one of the two study groups (patency or non-patency). It was ensured that neither the patient, nor the primary investigator was aware of the treatment protocol before completing the consent process. After administration of local anesthesia, rubber dam isolation of the involved tooth was done. Caries excavation was done and access cavity prepared using carbide burs in high speed handpiece with copious irrigation. Debridement of the pulp chamber was done and all canal orifices identified. Working length was obtained with the help of electronic apex locator (Root ZX) and confirmed radiographically. ProTaper S1 and Sx were used to flare coronal thirds and WL was reconfirmed with apex locator. Hand files No. 10, 15 and 20 were used till working length (WL) to prepare a smooth reproducible glide path. ProTaper S1 and S2 were used till WL, followed by the use of ProTaper finishing files (F1/F2/F3) to prepare the canal to desired size as determined by the operator. Copious irrigation with 3% Sodium Hypochlorite was carried out throughout the procedure with the use of 27-gauge side vented needle.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mature permanent mandibular first molars
- •Diagnosis of pulp necrosis, as confirmed by negative response to cold and electrical tests
- •Radiographic evidence of apical periodontitis (minimum size ≥ 2.0 × 2.0 mm)
- •Probing depth < 4mm
排除标准
- •Non willingness to participate in study
- •younger than 18 years of age
- •Pregnant, diabetic or immunocompromised
- •Prior endodontic treatment of the same tooth
- •History of antibiotic use in past one month or requiring antibiotic pre-medication
- •unrestorable teeth, fractured or perforated roots, grade 3 mobility
研究组 & 干预措施
Patency Group
apical patency was maintained during chemomechanical preparation
干预措施: Apical patency (Procedure)
Non Patency Group
Apical patency was not maintained during chemomechanical preparation
结局指标
主要结局
Change in periapical radiolucency
时间窗: Baseline to 12-month
The change observed in periapical radiolucency at the 12-month follow-up visit was used to assess the success of the treatment
次要结局
- Clinical success(Baseline to 12-month)