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临床试验/NCT07641933
NCT07641933招募中1 期

Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases: A Randomized Controlled Clinical Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
60
试验地点
1

研究概览

简要总结

The aim of this clinical trial is to evaluate anti-inflammatory effect of various intracanal medications:

  1. Calcium Hydroxide Slurry mixed with 3% Sodium Hypochlorite
  2. Calcium Silicate
  3. Calcium Hydroxide

In retreatment cases in terms of:

  1. Biological Evaluation: Biomarker (IL 1B)
  2. Radiographic Evaluation: CBCT
  3. Clinical Evaluation: Pain Score (VAS)

详细描述

Sixty patients presenting with failed root canal treated lower first molars with periapical lesion were included in this randomized controlled single-center clinical superiority trial with two parallel arms and randomly allocated to 3 equal groups (n = 20) according to the type of ICM used. Patients were randomly allocated to receive either Ca(OH)2 slurry that was prepared from pure Ca(OH)2 powder mixed with 3% NaOCl, calcium-silicate (Bio-C Temp) or calcium hydroxide (CH) as ICM. Teeth were instrumented using a rotary file system (M3 pro Gold) and irrigated with 3% NaOCl. Subsequently, the root canals were dressed with a Ca(OH)2 + NaOCl or calcium silicate (test groups) or Ca(OH)2 (control group). Periapical fluid samples were collected after accessing the root canal in the first visit and after the root canal dressing removal in the second visit 2 weeks later using paper point. Samples were transferred to the microbiology lab immediately and levels of pro-inflammatory marker (IL1B) were measured using a specific enzyme-linked immunosorbent assay (ELISA) immediately after the second visit to test the reduction in inflammatory marker level after intracanal medication usage. Also, preoperative and 12 months-postoperative radiographic evaluation by CBCT were obtained to measure volumetric reduction in lesion size using segmentation technique. And patients rated their pain pre-operatively and then after 6, 12, 24, 48, 72 h and 7 days using the VAS score. Clinical and radiographic follow-up evaluations were scheduled for 1 week, 1 month, 6 months and 12 months by examining the patient clinically using palpation and percussion tests and pain questionnaire and periapical digital radiographs to compare reduction in lesion size.

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 (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 21-45 years.
  • Medically free patients. (ASA Class 1)
  • Gender: males and females
  • Patients who are cooperative at operation and in attendance at scheduled follow-up visits.
  • Restorable root canal treated permanent lower first molars with periapical lesions.
  • Small (<5 mm) or medium periapical lesion size (5-10 mm)

排除标准

  • Patients with a history of allergic reactions to any of the study materials.
  • Teeth that become non-restorable after complete caries excavation.
  • Teeth that have mobility or deep periodontal pockets.
  • Teeth with internal or external resorption.

研究组 & 干预措施

Calcium Silicate Intracanal Medication

Experimental

Calcium silicate-based bioceramic Intracanal Medication as Bio C-Temp (Angelus)

干预措施: Calcium Silicate Intracanal Medication (Drug)

Calcium Hydroxide Slurry mixed with Sodium Hypochlorite

Experimental

Calcium Hydroxide slurry mixed with 3% Sodium Hypochlorite

干预措施: Calcium Hydroxide Slurry mixed with Sodium Hypochlorite Intracanal Medication (Drug)

Calcium Hydroxide

Active Comparator

Calcium Hydroxide Intracanal Medication (Control Group)

干预措施: Calcium Hydroxide (Ca(OH)2) Intracanal Medication (Drug)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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