Antibacterial Effects of Intracanal Medicaments in Acute Apical Abscesses (CAM-AAA)
Comparative Evaluation of the Antibacterial Efficacy of Calcium Hydroxide and a Calcium Silicate-Based Intracanal Medicament in Teeth With Acute Apical Abscesses Using Real-Time PCR: A Randomized Clinical Trial
研究概览
地位
条件
详细说明
Acute apical abscess is an endodontic infection characterized by localized inflammation, pain, swelling, and purulent exudate. Although chemomechanical root canal preparation substantially reduces the bacterial load, microorganisms may remain within the root canal system. Intracanal medicaments are therefore used between treatment sessions to improve microbial reduction.
In this randomized, parallel-group clinical trial, teeth diagnosed with acute apical abscess are allocated to receive either a calcium hydroxide intracanal medicament or a calcium silicate-based intracanal medicament. All teeth undergo standardized root canal treatment and irrigation procedures.
Microbiological samples are collected at three main treatment stages: before chemomechanical preparation, after chemomechanical preparation and irrigation, and after a 7- to 10-day intracanal medication period. Bacterial DNA is analyzed using SYBR Green Real-Time PCR. Universal 16S rRNA primers are used to quantify the total bacterial load. Selected bacterial species associated with endodontic infections are also evaluated.
The primary outcome is the change in total bacterial load between the post-instrumentation sample and the sample collected after intracanal medication. Secondary outcomes include changes in selected bacterial species and bacterial levels across the different sampling stages. The study aims to determine and compare the microbial effectiveness of the two intracanal medicaments in acute apical abscess cases.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Erzurum
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Erzurum、Erzurum、土耳其（türkiye）、25240
- 招聘中
- Ataturk University Faculty of Dentistry
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接触：
- Halit Aladağ, DDS, PhD
- 电话号码：+905414675965
- 邮箱：haladag@atauni.edu.tr
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Diagnosis of acute apical abscess
- A single-rooted permanent tooth requiring primary endodontic treatment
- Age between 18 and 65 years
- No history of systemic disease
- American Society of Anesthesiologists physical status classification I (ASA I)
- Provision of written informed consent
Exclusion Criteria:
- Previous endodontic treatment of the affected tooth
- Periodontal probing depth greater than 4 mm
- History of trauma involving the affected tooth
- Pregnancy or breastfeeding
- Immunodeficiency
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Calcium Hydroxide Group
After standardized chemomechanical root canal preparation, a calcium hydroxide-based intracanal medicament is placed into the root canal to 1 mm short of the working length and remains in the canal for 7 to 10 days.
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Calcium hydroxide-based intracanal medicament placed into the prepared root canal to 1 mm short of the working length for 7 to 10 days.
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实验性的：Calcium Silicate-Based Medicament Group
After standardized chemomechanical root canal preparation, a calcium silicate-based intracanal medicament is placed into the root canal to 1 mm short of the working length and remains in the canal for 7 to 10 days.
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Calcium silicate-based intracanal medicament placed into the prepared root canal to 1 mm short of the working length for 7 to 10 days.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Total Bacterial Load After Intracanal Medication
大体时间：From immediately after chemomechanical preparation to 7 to 10 days after intracanal medicament placement
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Total bacterial load will be quantified using universal 16S rRNA gene-based Real-Time PCR in samples collected after chemomechanical root canal preparation (S2) and after the 7- to 10-day intracanal medication period (S3).
The antibacterial effect will be evaluated as the change in log10 bacterial load from S2 to S3 and compared between the two intervention groups.
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From immediately after chemomechanical preparation to 7 to 10 days after intracanal medicament placement
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in the Levels of Selected Endodontic Bacterial Species
大体时间：From before chemomechanical preparation to 7 to 10 days after intracanal medicament placement
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The levels of Fusobacterium nucleatum, Prevotella intermedia, Porphyromonas endodontalis, Parvimonas micra, Treponema denticola, Streptococcus anginosus, Dialister pneumosintes, Campylobacter rectus, Filifactor alocis, and Olsenella uli will be evaluated using species-specific Real-Time PCR.
Changes between the samples collected before chemomechanical preparation (S1), after chemomechanical preparation (S2), and after intracanal medication (S3) will be assessed and compared between the intervention groups.
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From before chemomechanical preparation to 7 to 10 days after intracanal medicament placement
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Change in Total Bacterial Load After Chemomechanical Preparation
大体时间：From before to immediately after chemomechanical root canal preparation during the first treatment visit
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Total bacterial load will be quantified using universal 16S rRNA gene-based Real-Time PCR in samples collected before chemomechanical root canal preparation (S1) and immediately after chemomechanical preparation (S2).
The change in log10 bacterial load from S1 to S2 will be evaluated to determine the bacterial reduction achieved by the standardized chemomechanical preparation protocol.
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From before to immediately after chemomechanical root canal preparation during the first treatment visit
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ATAUNI-ENDO-AAA-01
- 16653 (其他赠款/资助编号：Atatürk University Scientific Research Projects Coordination Unit)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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