EFFECT OF CALCIUM SILICATE-BASED ROOT CANAL MEDICAMENT ON RELEASE OF BONE RESORPTION AND INFLAMMATION MEDIATORS IN PERIAPICAL LESIONS: A RANDOMISED CONTROLLED CLINICAL TRIAL
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 TGF beta ratio
研究概览
简要总结
Calcium hydroxide is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited.
The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on the release of RANKL/OPG, TNF-α, PGE-2 and TGF-β1 in root canal treated teeth with periapical lesions.
详细描述
Sixty patients were randomly divided into two groups using a web program according to the medication selected: Calcium silicate based root canal medicament or calcium hydroxide based root canal medicament.
After removing gutta-percha from the root canals, RANKL/OPG, TNF-α, PGE-2 and TGF- β1 samples were taken from the interstitial fluid of the apical tissues using three paper points.
At the second appointment, medicaments were removed and second sampling was performed using the same method. RANKL/OPG, TNF-α, PGE-2 and TGF- β1 levels were measured by enzyme-linked immunosorbent assay and their ratios were calculated.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incisor, canine, and premolar teeth that had previously undergone root canal treatment (cases with persistent and secondary disease) and presented with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis were included. Incisor, canine, and premolar teeth with only 1 root canal were included in the study to avoid untreated extra root canals and difficulties in the preparation, obturation, and restoration of molar teeth and to make treatments more standardized.The patients had not used any antibiotics for 3 months before treatment, and patients were obviously free of systemic diseases.
排除标准
- •Patients were excluded if teeth showed the presence of a root fracture or any swelling, ankyloses, or periodontal pockets deeper than 4 mm. Teeth on which a rubber dam could not be performed were excluded. 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 by an electronic apex locator with a 15-K file R25 and R50 Reciproc files were used at working lengths to complete the canal preparation. During instrumentation, the root canals were irrigated with 2 mL 1% NaOCl. To obtain the first samples, 3 sterile paper points were placed into the root canals beyond the 2-mm root apex and were kept in position for 60 seconds. Thereafter, the paper points were cut 4 mm from the tip30.
Afterward, root canals were dried with paper points, and calcium silicate based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length. Next, the coronal cavities were restored with temporary material.
Seven days later, the medication was mechanically removed using a master apical file. Subsequently, root canals were irrigated.The final samples were collected from the interstitial fluid of the apical tissue as previously described.
干预措施: Calcium Silicate (Drug)
calcium hydroxide based medicament
Root canal lengths were determined by an electronic apex locator with a 15-K file R25 and R50 Reciproc files were used at working lengths to complete the canal preparation. During instrumentation, the root canals were irrigated with 2 mL 1% NaOCl. To obtain the first samples, 3 sterile paper points were placed into the root canals beyond the 2-mm root apex and were kept in position for 60 seconds. Thereafter, the paper points were cut 4 mm from the tip30.
Afterward, root canals were dried with paper points, and calcium hydroxide based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length. Next, the coronal cavities were restored with temporary material.
Seven days later, the medication was mechanically removed using a master apical file. Subsequently, root canals were irrigated.The final samples were collected from the interstitial fluid of the apical tissue as previously described.
干预措施: Calcium Hydroxide (Drug)
结局指标
主要结局
preoperative and postoperative levels of TGF beta ratio
时间窗: one week
The amounts of TGF beta were measured using an enzyme-linked immunosorbent assay kit.
preoperative and postoperative levels of TNF alpha ratio
时间窗: one week
The amounts of TNF alpha were measured using an enzyme-linked immunosorbent assay kit.
preoperative and postoperative levels of RANKL/OPG ratio
时间窗: one week
The amounts of cytokines RANKL and OPG were measured using an enzyme-linked immunosorbent assay kit.
preoperative and postoperative levels of prostaglandinE2 (PGE2) ratio
时间窗: one week
The amounts of PGE2 were measured using an enzyme-linked immunosorbent assay kit.
次要结局
- dependent variables (sex, age, teeth number, smoking habit)(one week)
研究者
Meltem Sümbüllü
Assistant Professor
Ataturk University