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临床试验/NCT07329413
NCT07329413已完成不适用

Does Anterior Disc Displacement With Reduction Affect Postoperative Pain After Root Canal Treatment in Patients With Symptomatic Apical Periodontitis? A Prospective, Quasi-Experimental Controlled Study

Recep Tayyip Erdogan University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年3月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Postoperative pain intensity

研究概览

简要总结

The aim of this study is to evaluate the impact of anterior disc displacement with reduction (ADDR) on postoperative pain following root canal treatment in patients diagnosed with symptomatic apical periodontitis.

详细描述

This prospective clinical study included individuals diagnosed with symptomatic apical periodontitis who had a vital mandibular molar tooth and were diagnosed with anterior disc displacement with reduction (ADDR) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) (n = 45), as well as individuals without any temporomandibular joint pathology (n = 45). Following patient dropouts, a total of 70 patients with complete and eligible data were included in the final analysis, with 35 participants in each group.

All root canal treatments were performed by the same clinician using a standardized treatment protocol. Postoperative pain intensity was assessed using the Numeric Rating Scale at 6 and 12 hours and at 1, 2, 3, 5, and 7 days after treatment. In addition, joint sounds, joint pain, and maximum mouth opening were recorded in the preoperative period and at the 7-day postoperative follow-up, and their associations with postoperative pain were analyzed.

The findings of this study provide insight into the relationship between temporomandibular joint disorders and endodontic postoperative pain and may contribute to improved clinical understanding.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

An oral diagnosis and radiology specialist with more than 10 years of clinical experience evaluated the patients' endodontic treatment needs and performed the temporomandibular joint examination. Patients diagnosed with anterior disc displacement with reduction according to the Diagnostic Criteria for Temporomandibular Disorders were assigned to the experimental group, while individuals without temporomandibular joint disorders constituted the control group.

At this stage, both the participants and the clinician performing the root canal treatments were blinded to the temporomandibular joint status of the patients (double-blind). Group allocation was concealed until completion of the data analysis, resulting in a triple-blind study design.

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

入选标准

  • Individuals aged between 18 and 65 years with no systemic disease
  • Patients diagnosed with symptomatic apical periodontitis
  • Presence of a vital permanent mandibular first or second molar tooth requiring root canal treatment
  • Teeth with no radiographic evidence of periapical changes or only slight widening of the periodontal ligament space
  • Patients reporting preoperative spontaneous pain with a Numeric Rating Scale (NRS) score between 4 and 10 (moderate pain: 4-6; severe pain: 7-10)
  • Patients reporting pain intensity of 4 or higher on the NRS during percussion testing
  • Patients diagnosed with isolated anterior disc displacement with reduction according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) (experimental group) or patients without any temporomandibular joint disorder or pathology (control group)

排除标准

  • Teeth found to have necrotic pulp tissue during access cavity preparation
  • Patients in whom the study tooth was not located on the same side as the temporomandibular joint diagnosed with anterior disc displacement with reduction
  • Occurrence of any endodontic complications during treatment
  • Use of medications that could affect pain perception (e.g., analgesics or anti-inflammatory drugs) within at least 12 hours before treatment, or use of systemic antibiotics within one month prior to enrollment
  • History of major jaw trauma, dentofacial deformities, or previous temporomandibular joint surgery
  • Concurrent use of steroids, muscle relaxants, or narcotic medications
  • History of diagnosed neuropathic pain, myofascial pain, neuralgic pain, or chronic headache disorders
  • Presence of periodontal disease (probing depth > 5 mm or tooth mobility greater than Grade I) or teeth lacking adequate coronal structure
  • Teeth without occlusal contact or with premature contacts, patients with bruxism or clenching habits, or patients with fewer than three teeth on one side of the mandible
  • Inability to read, understand, or complete the pain assessment scale or to provide the required follow-up data
  • Presence of significant cognitive impairment (e.g., communication deficits, intellectual disability) or diagnosed psychiatric disorders (e.g., depression, anxiety disorders)
  • Presence of immature teeth or teeth with open apices
  • Pregnant or breastfeeding women

研究组 & 干预措施

ADDR group

Experimental

Patients diagnosed with anterior disc displacement with reduction according to the Diagnostic Criteria for Temporomandibular Disorders.

干预措施: Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold) (Procedure)

ADDR group

Experimental

Patients diagnosed with anterior disc displacement with reduction according to the Diagnostic Criteria for Temporomandibular Disorders.

干预措施: Ibuprofen 400 mg (if necessary) (Drug)

Control group

Active Comparator

Patients without any temporomandibular joint pathology.

干预措施: Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold) (Procedure)

Control group

Active Comparator

Patients without any temporomandibular joint pathology.

干预措施: Ibuprofen 400 mg (if necessary) (Drug)

结局指标

主要结局

Postoperative pain intensity

时间窗: 6, 12 hours 1, 2, 3, 5 and 7 days postoperatively

To evaluate postoperative pain, each patient was provided with a pain diary after root canal treatment and was instructed to record pain intensity using the Numeric Rating Scale (NRS). Detailed instructions on how to use the NRS were given to all participants. Pain intensity was recorded at 6, 12, 24, 48, and 72 hours and at 5 and 7 days after treatment. Patients were prescribed 400 mg ibuprofen for use only in cases of severe pain. Data from patients who used analgesics during the follow-up period were excluded from the analysis.

次要结局

  • Maximum mouth opening(Baseline and 7 days postoperatively)
  • Temporomandibular joint pain and percussion sensitivity(Baseline and 7 days postoperatively)

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

burcu revi

Principal Investigator

Recep Tayyip Erdogan University

研究点 (1)

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