Comparative Evaluation of the Effects of Calcium Hydroxide and BIO-C Temp Medicaments on Postoperative Pain in Patients Undergoing Endodontic Treatment: a Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Interappointment Pain Intensity
研究概览
简要总结
This clinical study is designed to evaluate postoperative pain experienced by patients undergoing multi-visit endodontic retreatment and to investigate whether the choice of intracanal medicament influences pain levels between treatment sessions. Postoperative pain is a common concern following root canal procedures and may negatively affect patient comfort, treatment satisfaction, and overall perception of dental care.
Calcium hydroxide has long been used as a conventional intracanal medicament in endodontic therapy due to its antimicrobial properties. In recent years, bioceramic-based materials such as Bio-C Temp have been introduced as alternative intracanal medicaments, with proposed advantages related to biocompatibility and interaction with dental tissues. However, limited clinical evidence is available regarding their effect on postoperative pain when compared with conventional materials.
In this study, patients requiring multi-visit endodontic retreatment will receive either calcium hydroxide or Bio-C Temp as an intracanal medicament between treatment sessions. Pain intensity will be evaluated at specific time points following treatment using standardized pain assessment scales. In addition to pain intensity, the use of analgesic medication will also be recorded.
The primary objective of this study is to compare interappointment postoperative pain levels associated with calcium hydroxide and Bio-C Temp. Secondary objectives include evaluating analgesic consumption. By comparing a conventional intracanal medicament with a newer bioceramic-based alternative, this study aims to contribute to a better understanding of how intracanal medicament selection may influence postoperative pain and patient experience during endodontic retreatment.
The findings of this study may help clinicians make more informed decisions regarding intracanal medicament selection and improve pain management strategies in endodontic practice.
详细描述
This clinical study is a comparative investigation designed to evaluate interappointment postoperative pain in patients undergoing multi-visit endodontic retreatment. Postoperative pain is a frequent concern in endodontic practice and may affect patient comfort, treatment compliance, and overall satisfaction. The study focuses on whether the choice of intracanal medicament used between treatment sessions influences postoperative pain levels and patient-reported outcomes.
Study Design
The study is conducted as a clinical, comparative study involving patients who require multi-visit endodontic retreatment of single-rooted teeth. Following the initial treatment session, eligible patients are assigned to receive one of two intracanal medicaments during the interappointment period.
Participants
Patients included in the study are systemically healthy individuals classified as ASA Physical Status I, presenting with single-rooted teeth requiring endodontic retreatment and exhibiting normal root anatomy. Patients with conditions or factors that could influence pain perception or treatment outcomes are excluded. All participants provide informed consent prior to enrollment.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors are blinded to the intracanal medicament used. The intracanal medicaments are applied by a separate investigator who is aware of the treatment assignment but is not involved in outcome assessment or data analysis. Outcome assessments are performed using coded patient records to maintain blinding.
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
- •• Patients with single-rooted teeth requiring endodontic retreatment.
- •Individuals in good general health, classified as ASA Physical Status I.
- •Teeth presenting normal anatomical structure and root morphology.
排除标准
- •• Patients who have used antibiotics or analgesic medications within the last month.
- •Pregnant individuals and patients with systemic diseases (such as chronic illnesses, diabetes mellitus, hypertension).
- •Teeth with root fractures or perforations.
- •Teeth with complex root canal anatomy, multirooted teeth, or severely curved roots.
- •Patients presenting with high baseline pain levels, particularly those with a history of treatment-resistant pain.
研究组 & 干预措施
Bio-C Temp Group
Patients receive Bio-C Temp, a bioceramic-based intracanal medicament, placed in the root canal system during the interappointment period of multi-visit endodontic retreatment.
干预措施: bioceramic based intracanal medication (Drug)
Calcium Hydroxide Group
Patients receive calcium hydroxide as an intracanal medicament placed in the root canal system during the interappointment period of multi-visit endodontic retreatment.
干预措施: Calcium Hydroxide Intracanal medication (Drug)
结局指标
主要结局
Interappointment Pain Intensity
时间窗: 12 hours, 24 hours, 3 days, 5 days, 7 days
* What is measured: Postoperative pain intensity will be measured using a patient-reported Visual Analog Scale (VAS). * Instrument and range: The VAS is a 10 cm line anchored at 0 cm ("no pain") and 10 cm ("worst possible pain"); participants mark their pain level on this line . * Unit and interpretation: Scores range from 0 to 10; higher scores indicate a worse outcome (more pain). The unit of measure is VAS score (0-10).
次要结局
- Analgesic Consumption(Up to 24 hours post-treatment; up to 3 days post-treatment; up to 5 days post-treatment; up to 7 days post-treatment.)
研究者
Assist.Prof.Emine ODABAŞI TEZER
Assistant Professor
Ankara University