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临床试验/NCT07710833
NCT07710833已完成不适用

Effect of Intracanal Cryotherapy on Endodontic Postoperative Pain in Teeth With Asymptomatic Irreversible Pulpitis and Asymptomatic Apical Periodontitis: A Four-Arm Randomized Controlled Trial

Recep Tayyip Erdogan University1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2026年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
132
试验地点
1
主要终点
Between- and Within-Group Comparisons of Postoperative Pain Scores Over Time

研究概览

简要总结

This study aimed to evaluate the effects of cooled and room-temperature NaOCl irrigation on postoperative endodontic pain in single-rooted teeth diagnosed with asymptomatic irreversible pulpitis (AIP) or asymptomatic apical periodontitis (AAP).

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy patients with 18-70 years of age
  • Single-rooted teeth with a single root canal, diagnosed with either AIP and normal periapical tissues or AAP.
  • Pulpal and periapical diagnoses were established according to the American Association of Endodontists (AAE) [20] diagnostic terminology. Included teeth were categorized into 2 diagnostic groups: AIP with normal periapical tissues and AAP associated with pulp necrosis. AIP was provisionally diagnosed in teeth with extremely deep caries approximating or reaching the pulp, a positive response to cold testing (Dispodent, Nadu, India), and no clinical symptoms. Periapical radiographs showed a PAI score of 1 without periodontal ligament widening. The diagnosis was confirmed intraoperatively by persistent pulpal bleeding that remained uncontrolled after 10 minutes of application of a sterile cotton pellet moistened with 2.5% sodium hypochlorite. AAP was diagnosed in teeth with a PAI score of ≥3 in the absence of clinical symptoms. None of the included teeth exhibited tenderness to percussion. All periapical radiographs were obtained using a phosphor storage plate system and the paralleling technique (Myray parallel holder, NDental, Imola, Italy) under standardized exposure parameters (70 kV, 8 mA, 0.360 s).

排除标准

  • Teeth with canal calcification, complex or atypical canal anatomy, root resorption, incomplete root development, or a history of endodontic treatment of the study tooth.
  • 2) Teeth initially diagnosed with AIP in which pulpal bleeding was controlled within 10 min after access cavity preparation, as these teeth were considered eligible for vital pulp therapy.
  • 3) Teeth initially diagnosed with AIP in which pulp necrosis was identified after access cavity preparation.
  • 4) Teeth in which root canal treatment could not be completed in a single visit.
  • 5) Patients who had taken analgesics within 12 hours before the appointment or antibiotics within the previous month.
  • 6) Teeth with periodontal probing depths >3 mm or clinical/radiographic signs of periodontal disease.
  • 7) Teeth with insufficient coronal tooth structure to allow an adequate ferrule.
  • 8) Pregnant or breastfeeding patients and patients with systemic conditions or regular medication use that could affect treatment outcomes.

结局指标

主要结局

Between- and Within-Group Comparisons of Postoperative Pain Scores Over Time

时间窗: During the first week after treatment

次要结局

未报告次要终点

研究者

发起方
Recep Tayyip Erdogan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Medine Ciçek

department of endodontics, research assistant

Recep Tayyip Erdogan University

研究点 (1)

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