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临床试验/NCT06403293
NCT06403293已完成不适用

Influence of Sonic Activation of Epoxy Resin and Calcium Silicate Sealer on Post-Operative Pain: A Patient-Blinded, Randomised Clinical Trial

Mustafa Kemal University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
post operative pain

研究概览

简要总结

Aim: This clinical study aims to compare post-operative pain after single-visit root canal treatment of teeth with asymptomatic apical periodontitis using epoxy-resin based AH Plus and calcium silicate based Endosequence BC sealers with or without sonic activation.

Materials and Methods: The study included 72 individuals having one first or second mandibular premolar tooth with asymptomatic apical periodontitis. They were randomly divided into 4 groups according to the root canal sealer (AH Plus or Endosequence BC) and activation protocol (sonic activation or non-activation) (n=18). Participants were ask to rate their post-operative pain intensity on a NRS scale as none, minimal, moderate, or severe after 24 h, 48 h, 72 h and 7 days following treatment. Patients were also asked to record the number of prescribed analgesic medication tablets (ibuprofen 400 mg) taken. The collected data were statistically analyzed at 0.05 significance level.

详细描述

Root Canal Treatment After inferior alveolar nervus block anesthesia with 4% Articaine with 1:100,000 adrenaline, the tooth was isolated with a rubber dam. The access cavity was opened using high-speed diamond round burs under water cooling. The working length (WL) was set at 0.5 mm shorter than the 0.0 reading using a 15 K-type file and apex locator (Morita Root ZX, Japan) and checked with radiographs. The root canals were prepared with Resiproc (Resiproc, VDW, Munich, Germany) R25 and R40 files, respectively, at the WL using the crown down technique. A total of 20 mL of 2.5% sodium hypochlorite (NaOCl) was used with a 30-gauge needle (Max-i-Probe; Dentsply Sirona) during preparation. 5 mL of distilled water was left in the canal for 1 min to neutralize the effect of NaOCl, and then the root canals were irrigated with 3 ml of 17% ethylene diamine tetra acetic acid (EDTA). EDTA was activated for 3 × 20s with the EA 25/04 tip 2 mm shorter than the WL. The EA tip was used with 2-4 mm vertical strokes. The root canals were irrigated with 5 mL distilled water and dried with paper points.

The subjects were divided into four groups for root filling. Randomization was performed using online software (www.randomizer.org) with a four-block-sized block randomization technique to ensure even distribution between the groups (allocation ratio 1:1:1:1). A co-investigator managed the allocation and reported the allocated treatment procedure to the operator. The operator could not be blinded due to the different stages of the treatment protocols. The patients were blinded to the chosen root canal sealer and activation protocol.

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 (Participant)

盲法说明

The patients were blinded to the chosen root canal sealer and activation protocol.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Mandibular first and second premolar teeth diagnosed with asymptomatic apical periodontitis
  • •Single rooted teeth with a single canal.

排除标准

  • •Previous root canal treatment
  • •Use of any analgesic or antibiotics in the last 7 days
  • •Symptomatic teeth
  • •Sinus tract
  • •Presence of advanced periodontal problem (probing depth >4 mm)
  • •Complications during treatment such as broken file, ledging
  • •Teeth with extensive coronal destruction.

研究组 & 干预措施

AH Plus-NA

Experimental

AH Plus was mixed according to the manufacturer's instructions. The R40 gutta-percha (VDW) was coated with the sealer and inserted into the canal, and the root canals were filled using the single cone technique (SCT). The sealer was not activated.

干预措施: Root canal treatment (AH Plus-NA) (Procedure)

AH Plus- EA

Experimental

An EA 25/04 tip was coated with AH Plus and activated in the root canals for 10 seconds. Then, the R40 gutta-percha was coated with the sealer and inserted into the canal, and the root canals were filled using SCT.

干预措施: Root canal treatment (AH Plus-EA) (Procedure)

BC-NA

Experimental

The ready-to-use EndoSequence BC was injected into the root canals and no activation was performed. Then, the R40 gutta-percha was inserted into the canali and the root canals were filled using SCT.

干预措施: Root canal treatment (BC-NA) (Procedure)

BC-EA

Experimental

EndoSequence BC was injected into the root canals. An EA 25/04 tip was inserted 2 mm beyond the WL and activated for 10 s. Then, the R40 gutta-percha was inserted into the canal and the root canals were filled using SCT.

干预措施: Root canal treatment (BC-EA) (Procedure)

结局指标

主要结局

post operative pain

时间窗: 1 week

All participants were given a questionnaire based on a 0-10 numeric rating scale (NRS), with 0 indicating no pain and 10 indicating the worst pain. Patients recorded their pain on days 1, 2, 3 and 7 after treatment. Pain intensity was rated into 4 categories using the NRS. None: (NRS 0); Mild (NRS 1-3); Moderate (NRS 4-7); Severe (NRS 8-10).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Sari

Assistant Professor

Mustafa Kemal University

研究点 (1)

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