The Effect of Apical Patency on Postoperative Pain Following Root Canal Treatment of Single-Rooted Teeth: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
The goal of this randomized controlled clinical trial was to evaluate whether implementing apical patency affects the intensity of postoperative pain after single-visit root canal treatment in asymptomatic, vital, single-rooted teeth.
The main question it aims to answer is:
Does maintaining apical patency by gently extending a #10 K-file 1 mm beyond the working length during canal shaping influence postoperative pain compared with instrumentation confined within the working length?
In the patency group, the working length was determined with an electronic apex locator and radiograph, and then apical patency was maintained by passively extending a #10 K-file 1 mm beyond the working length at each instrument change to prevent apical blockage, remove debris, and facilitate irrigant delivery to the apical terminus.
In the non-patency group, the working length was likewise established with an electronic apex locator and radiograph, but all subsequent instrumentation was confined within the working length and no file was advanced beyond the apical foramen.
In both groups, all other clinical procedures-including anesthesia, rubber dam isolation, access cavity preparation, rotary canal shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation with gutta-percha and epoxy resin-based sealer, and definitive composite restoration-were performed in a single visit using the same protocol. Postoperative pain was recorded on a Numerical Rating Scale (NRS) at 0-6, 6-12, 12-24, 24-36, and 36-48 hours, and analgesic intake within 48 hours was documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18-65 years, classified as ASA I or ASA II according to the American Society of Anesthesiologists (ASA), who had not taken analgesics for at least 6 hours prior to treatment.
- •Asymptomatic, single-rooted vital teeth without spontaneous pain (including teeth perforated during prosthetic preparation or teeth adjacent to a cyst in an area scheduled for cyst surgery).
- •Radiographic evidence of mature apices with no periapical pathology; periodontal probing depth ≤ 3 mm; and gingival health meeting Glickman's criteria.
- •Individuals who are literate, able to provide written informed consent, and capable of understanding and using the pain scale.
排除标准
- •Patients who are pregnant or have a cardiac pacemaker.
- •Patients who used antibiotics within the past month or who required antibiotic prophylaxis.
- •Presence of extensive restorations in the tooth of interest.
- •Patients reporting concurrent pain in adjacent teeth.
- •Dental or orofacial pain of non-endodontic origin.
研究组 & 干预措施
Non-Patency Group
Preoperative pain was recorded using a Numerical Rating Scale (NRS) before treatment. All procedures were performed in a single visit by one operator under 3× magnification. Local anesthesia was achieved with 4% articaine containing 1:100,000 epinephrine. After rubber dam isolation, caries and existing restorations were removed and an endodontic access cavity was prepared under copious water cooling using high-speed sterile diamond burs.
The working length was established with an electronic apex locator (Root ZX Mini) and confirmed radiographically. In this group, apical patency was not maintained: after working length determination, all subsequent instrumentation was confined within the working length, and no file was advanced beyond the apical foramen.
Root canals were shaped using the One Curve NiTi rotary system (25/.06 or 35/.04) with a crown-down technique. During shaping, canals were irrigated with a total of 10 mL of 2.5% sodium hypochlorite (2 mL after each shaping step) de
干预措施: Root canal treatment without apical patency (Procedure)
Patency Group
Preoperative pain was recorded using a Numerical Rating Scale (NRS) before treatment. All procedures were performed in a single visit by one operator under 3× magnification. Local anesthesia was achieved with 4% articaine containing 1:100,000 epinephrine. After rubber dam isolation, caries and existing restorations were removed and an endodontic access cavity was prepared under copious water cooling using high-speed sterile diamond burs.
The working length was established with an electronic apex locator (Root ZX Mini) and confirmed radiographically. In this group, apical patency was maintained: a #10 K-file was gently advanced 1 mm beyond the working length at each instrument change to prevent apical blockage, remove accumulated debris, and facilitate irrigant delivery to the apical terminus.
Root canals were shaped using the One Curve NiTi rotary system (25/.06 or 35/.04) with a crown-down technique. During shaping, canals were irrigated with a total of 10 mL of 2.5% sodium hypochl
干预措施: Root canal treatment with apical patency (Procedure)
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: Up to 48 hours after treatment.
The numerical rating scale for pain is an 11-point scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable. The patient is asked to choose the number that best represents the intensity of pain he or she feels at that moment. It is used to assess the severity of postoperative pain and to help evaluate the need for and response to analgesic medication. Also called NRS.
次要结局
未报告次要终点
研究者
Kübra Gürler
Pricipal Investigator
Cukurova University