Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Clinical success
研究概览
简要总结
.There is no general agreement regarding the optimal concentration of sodium hypochlorite to be used in endodontic treatment.Therefore, this study aims to evaluate the effect of sodium hypochlorite concentration on the success of primary root canal treatment. The study population comprised of patients requiring primary root canal treatment following the diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular first and second molars.Patients were randomly allocated in either High concentration or Low concentration group.
详细描述
AIMS AND OBJECTIVES
- To evaluate the success of primary endodontic treatment following use of 5% and 1% NaOCl in non-vital, posterior teeth.
- To compare the success achieved following use of the two different concentrations of NaOCl.
- To evaluate postoperative pain following use of 5% and 1% NaOCl.
MATERIALS AND METHODS: Mature mandibular first and second molars with diagnosis of pulp necrosis (as confirmed by negative response to cold and electric pulp testing), and having apical radiolucency were chosen for the study.The consenting subjects were allocated to one of the two study groups based on concentration of NaOCl used: 5% [high concentration (HC)] and 1% [low concentration (LC)].Using an equal proportion randomization allocation ratio, envelopes containing concealed assignment codes were assigned sequentially to eligible patients.It was ensured that neither the patient, nor the primary investigator was aware of the treatment protocol before beginning of the treatment procedure.
CLINICAL PROCEDURE:
2% lidocaine with 1/80000 epinephrine was used to achieve profound local anaesthesia.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient willingness to participate in the study
- •Mature permanent mandibular first and second molars requiring primary root canal treatment
- •Diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber
- •Radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm)
- •Patient's age more than 18 years
- •Exclusion Criteria
- •Positive history of antibiotic use within past one month of the treatment.
- •Positive history of analgesic use within the past 3 days.
- •Patients who are pregnant, diabetic, immunocompromised, had serious medical illness or required antibiotic premedication
- •Patients with pockets ≥4mm or having marginal or furcal bone loss due to periodontitis
- •Teeth that are not suitable for rubber dam isolation
- •Previously accessed teeth and/or with procedural errors
- •Unrestorable tooth, fractured/ perforated roots, inflammatory root resorption
排除标准
- 未提供
研究组 & 干预措施
Root canal treatment with 5% NaOCl
Root canal treatment with 5% NaOCl: 5 ml of 5% sodium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 5% sodium hypochlorite.
干预措施: Root canal treatment with 5% NaOCl (Procedure)
Root canal treatment with 1% NaOCl
5 ml of 1% soium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 1% sodium hypochlorite.
干预措施: Root canal treatment with 1% NaOCl (Procedure)
结局指标
主要结局
Clinical success
时间窗: Till 12 months
Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.
Radiographic success
时间窗: Every 3 months till 12 months
Treatment outcome was judged on the basis of radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit.Change in Periapical Index (PAI) scores observed at 12-months was noted and scoring of each tooth was done according to the PAI scores and score less than 3 were considered as success.
次要结局
- Pain intensity(Pain intensity recorded at different intervals (preoperatively, after 6 hours, 12 hours, 1day, 2 days, 3 days, 4days, 5 days, 6 days and 7 days).)