Evaluation of the Effect of Calcium Silicate-Based Root Canal Medicament on Antifungal-Antibacterial Activity and Post-Operative Pain After Retreatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- preoperative and postoperative levels of bacterial loud
研究概览
简要总结
Calcium hydroxide is generally preferred in endodontics as an intracanal medicament due to its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited. A new calcium silicate-based root canal medicament has been developed as an alternative to calcium hydroxide-based medicaments.
The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on antibacterial, antifungal activity, and postoperative pain in root canal-treated teeth with periapical lesions.
详细描述
Sixty patients were randomly divided into two groups using a web-based program according to the selected medicament (calcium silicate-based root canal medicament or calcium hydroxide-based root canal medicament).
After the removal of gutta-percha from the root canals, the first samples were collected using paper points to evaluate antibacterial and antifungal effects. The root canals were then chemomechanically prepared, followed by final irrigation activation, and the second samples were collected. The selected root canal medicament was placed in the canals, and the patients were given a form to record their postoperative pain levels over one week.
At the second appointment, the medicaments were removed, and third samples were collected using paper points to assess antibacterial and antifungal effects. The root canal treatments of the patients were then completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.
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)
盲法说明
outcome assessments have performed by a investigator who was blinded to groups.
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
- •healthy patients with aged between 18-
- •Incisor, canine, and premolar teeth that had previously undergone root canal treatment
- •Incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis
- •teeth with only 1 root canal
- •the patients had not used any antibiotics for 3 months before treatment
排除标准
- •the presence of a root fracture
- •teeth with any swelling
- •ankyloses,
- •periodontal pockets deeper than 4 mm.
- •teeth which a rubber dam could not be performed
- •patients with allergy to ibuprofen or ciprofloxacin were also excluded.
研究组 & 干预措施
calcium silicate based medicament
Root canal lengths were determined using an electronic apex locator and a 15-K file. R25 Reciproc files were used at working lengths to remove the root canal filling. During instrumentation, the root canals were irrigated with saline solution. To obtain the first samples, three sterile paper points were placed at working length and the samples were transferred to an Eppendorf tube containing distilled water.
Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and the second samples were collected in the same manner. The calcium silicate-based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to assess the patients' postoperative pain levels over one week.
At the second appointment, the medicament was removed, and third samples were collected using paper points with the same technique to evaluate antibacterial and antifungal effects. The root canal treatments of
干预措施: Calcium Silicate (Drug)
calcium hydroxide based medicament
Root canal lengths were determined using an electronic apex locator and a 15-K file. R25 Reciproc files were used at working lengths to remove the root canal filling. During instrumentation, the root canals were irrigated with saline solution. To obtain the first samples, three sterile paper points were placed at working length and the samples were transferred to an Eppendorf tube containing distilled water.
Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and the second samples were collected in the same manner. The calcium hydroxide based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to assess the patients' postoperative pain levels over one week.
At the second appointment, the medicament was removed, and third samples were collected using paper points with the same technique to evaluate antibacterial and antifungal effects. The root canal treatments of
干预措施: Calcium hydroxide (Drug)
结局指标
主要结局
preoperative and postoperative levels of bacterial loud
时间窗: one week
The amounts of antibacterial loud was measured using a PCR kit.
preoperative and postoperative levels of antifungal loud
时间窗: one week
The amounts of antifungal loud was measured using a PCR kit.
postoperative pain levels
时间窗: one week
postoperative pain levels will be describe using the visual analog scale (VAS). The VAS was classified using the following scale \[15\]: no pain (0); mild pain (1-3); moderate pain (4-6), and severe pain (7-10).
次要结局
未报告次要终点
研究者
Meltem Sümbüllü
Assistant Professor Dr. Meltem Sümbüllü
Ataturk University