Comparison of Single-Visit Endodontic Treatment Outcomes Using Continuous Wave Condensation and Single-Cone Obturation Techniques: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The rate of 6-month treatment success
研究概览
简要总结
The goal of this clinical trial is to compare two root canal obturation techniques for endodontic treatment in patients aged 15 to 56 years with irreversible pulpitis. The main questions it aims to answer are:
- Does continuous wave condensation differ from the single-cone technique in obturation time?
- Does continuous wave condensation differ from the single-cone technique in obturation quality, postoperative pain, and 6-month treatment success? Researchers will compare continuous wave condensation with single-cone obturation to see whether one technique provides better sealing quality, shorter treatment time, less postoperative pain, or higher clinical success.
Participants will:
- Receive endodontic treatment for teeth diagnosed with irreversible pulpitis.
- Undergo root canal preparation with Reciproc Blue R25.
- Have canals obturated using either continuous wave condensation or the single-cone technique.
- Be evaluated for obturation time, radiographic quality immediately after treatment, postoperative pain at 4, 24, 48, and 72 hours, and clinical-radiographic outcome at 6 months.
详细描述
Background and Rationale: Irreversible pulpitis requires endodontic treatment to eliminate infection, prevent reinfection, and preserve tooth function. Effective three-dimensional obturation of the root canal system (RCS) is critical for long-term success. The single-cone (SC) technique offers procedural simplicity and reduced chair time but may compromise adaptation to complex canal anatomy. Continuous wave condensation (CWC) uses thermoplasticized gutta-percha to improve sealing of lateral canals and isthmuses. Despite widespread clinical use, comparative clinical data on obturation time, radiographic quality, postoperative pain, and short-term outcomes remain limited, particularly in irreversible pulpitis cases without periapical pathology.
Study Design:
This single-center, superiority, parallel-group randomized clinical trial compared CWC and SC obturation techniques in 60 teeth from 54 patients. Randomization occurred at the tooth level (1:1 allocation) using sequentially numbered opaque sealed envelopes. Operators (two calibrated endodontists) were unblinded due to technique differences; radiographic and clinical assessors remained blinded.
Interventions:
All teeth underwent standardized single-visit treatment under local anesthesia:
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 (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
- 否
入选标准
- •Teeth diagnosed with irreversible pulpitis
- •Indicated for endodontic treatment
- •Patients aged 18-60 years
排除标准
- •Periapical/furcation lesions;
- •Need for periodontal surgery
- •Periodontal pockets ≥ 5 mm
- •Adjacent teeth undergoing endodontic treatment
- •Severely fractured or non-restorable crowns
- •Immature/abnormal roots
- •Internal or external resorption
- •Calcified/C-shaped canals
- •Canal curvature >70°
- •Failures during canal preparation
研究组 & 干预措施
CWC
Continuous Wave Condensation (EQ-V system, Meta Biomed): Heated plugger at 230°C, apical compaction, thermoplastic backfill.
干预措施: Continuous Wave Condensation (Procedure)
SC
Single-Cone: Gutta-percha cone + sealer to working length, heat trim excess.
干预措施: Single-Cone (Procedure)
结局指标
主要结局
The rate of 6-month treatment success
时间窗: 6 months
clinical/radiographic per European Society of Endodontology criteria
次要结局
- Obturation time(from insertion of master gutta-percha cone with sealer until completion of obturation procedure (final condensation/backfill completed))
- Percentage of canals with adequate obturation length (±2 mm from radiographic apex) assessed by periapical radiograph(Immediately post-obturation, within 5 minutes after the obturation procedure is completed.)
- Percentage of canals/tooth with the presence of voids (radiolucency within filling material) assessed by periapical radiograph(Immediately post-obturation: within 5 minutes after the obturation procedure is completed.)
- Percentage of canals/tooth with apical sealer/gutta-percha extrusion (material beyond radiographic apex) assessed by periapical radiograph(Immediately post-obturation: within 5 minutes after the obturation procedure is completed.)
- Percentage of tooth with the presence of gutta-percha filling in accessory/lateral canals assessed by periapical radiograph(Immediately post-obturation: within 5 minutes after the obturation procedure is completed.)
- Postoperative pain intensity assessed by Numeric Rating Scale (NRS 0-10)(4 hours post-obturation; 24 hours post-obturation; 48 hours post-obturation; 72 hours post-obturation)
研究者
Nguyen Thi Nhat Vy
Principal Investigator
Hue University of Medicine and Pharmacy