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临床试验/NCT07210177
NCT07210177进行中(未招募)不适用

Clinical and Radiographic Evaluation of Root Canal Treatments Performed Using Two Different Intracanal Medicaments

Ege University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
1
主要终点
Post-operative Pain

研究概览

简要总结

Previously untreated, asymptomatic, single-rooted maxillary anterior teeth with periapical lesions <5 mm, no fractures, resorption, calcification, or recent antibiotic use will performed two-visit root canal treatment. Initial radiographs will be taken. After rubber-dam isolation, working length will be determined; canals prepared step-back to size #40 with sodium hypochlorite (NaOCl) irrigation, rinsed and dried. Between appointments, Metapaste or Bio-C TEMP will be placed as intracanal medicament for 7-10 days. At the second appointment medicaments removed, final irrigation performed and root canals obturated and restored. Pain scores recorded at 6h,12h,1d,2d,3d,4d,5d,6d,7d ; follow-ups at 6, 12 and 24 months.

详细描述

Within the scope of the project, two-visit root canal treatment will be performed on previously untreated, asymptomatic, single-rooted, single-canaled maxillary anterior teeth that have periapical lesions smaller than 5 mm on radiographs, no fractures or cracks, no internal or external resorption, no canal calcification, and no antibiotic use within the last week.

At the start of treatment, an initialradiograph will be taken of the tooth using a parallel film holder and archived. After rubber dam isolation, an access cavity will be prepared (all previous restorations will be removed if present). Working length will be determined by an apex locator. Root canal preparation will be performed using the step-back technique, with apical enlargement to at least size #40. Continuous irrigation with 2.5% NaOCl will be performed between each file. After instrumentation, the root canals will be rinsed with distilled water and dried with paper points.

Between appointments, to achieve additional disinfection of the root canals, Metapaste containing Ca(OH)₂ intracanal medicament (Meta Biomed Co., Ltd., Chungcheongbuk-do, Korea) and the bioceramic-based intracanal medicament Bio-C TEMP (Angelus, Paraná, Brazil) will be placed in the root canals according to the manufacturers' instructions. The intracanal distribution of the medicaments will be checked visually and radiographically, and the medicaments will be left in place for 7-10 days. Patients will be instructed on how to record their pain scores on the NRS scale and will be provided with contact information in case of any swelling or pain.

At the second appointment, after removal of the medicaments, a periapical radiograph will be taken for gutta-percha trial and verified according to the working length. In the final irrigation procedure, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), 5 mL of 2.5% NaOCl, distilled water and 2% chlorhexidine will be used respectively. After drying the root canals with paper points, they will be obturated with gutta-percha and a resin-based sealer using the cold lateral compaction technique, and the access cavities will be restored with composite resin. A final radiograph will be taken using the parallel technique with a parallel film holder.

Patients will again be given the NRS form and asked to return the completed forms after 7 days. Clinical follow-ups will be performed at the 6th, 12th, and 24th months, and follow-up radiographs will be taken using a parallel film holder. Changes in the size of the periapical lesions compared to baseline will be evaluated.

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
Triple (Participant, Investigator, 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
是

入选标准

  • •with a non-contributory medical history, mature maxillary incisor teeth with periapical lesions, diagnosed as asymptomatic apical periodontitis

排除标准

  • •clinical symptoms, drainage, more than 5 mm loss of periodontal attachment, Teeth with periapical lesions larger than 5 mm previous endodontic treatment, non-restorable tooth patient with taken antibiotic or analgesics

研究组 & 干预措施

Two visit root canal treatment with Bio-C TEMP

Active Comparator

Two-visit root canal treatment will be performed on the study teeth. Bio-C TEMP (Angelus, Paraná, Brazil), a bioceramic-based intracanal medicament, will be placed in the root canals between appointments according to the manufacturer's instructions.

干预措施: Bio-C Temp Intracanal Medication (Other)

Two visit root canal treatment with Meta Paste

Active Comparator

Two-visit root canal treatment will be performed on the study teeth. Meta Paste(Meta Biomed Co., Ltd., Chungcheongbuk-do, Korea) a calcium hydroxide based intracanal medicament, will be placed in theroot canals between appointments according to the manufacturer's instructions.

干预措施: Metapaste Intracanal Medication (Other)

结局指标

主要结局

Post-operative Pain

时间窗: Immediately after treatment, between appointments and after obturation for up to 7 days postoperatively

Following two -visit root canal treatment performed with different intracanal medicament types , the Numerical Rating Scale (NRS) was used to assess both inter-appointment and after obturation. Compare the patients' pain levels, and the patients were instructed to record their pain at 6, 12, 24, 48, and 72 hours, as well as on the 7th day. Patients were informed that a score of 0 represented no pain, while a score of 10 represented the maximum pain, with higher scores indicating greater pain intensity

次要结局

  • Changes in the size and the PAI score of the periapical lesion(At 6,12 and 24 months after treatment.)

研究者

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

Seniha Miçooğulları Kurt

Associate Professor

Ege University

研究点 (1)

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