Outcome of Calcium Silicate Sealer-based Obturation in Root Canal Retreatment: A CBCT-based Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)
研究概览
简要总结
This study will evaluate the outcome of calcium silicate sealer-based obturations in root canal retreatment.
详细描述
Calcium silicate sealer-based obturations have shown promising performance in primary root canal treatments, but there is a lack of prospective studies evaluating their effectiveness in secondary root canal treatments, which often involve more persistent microbial challenges. The aim of this study is to assess the clinical and radiographic outcomes of calcium silicate sealer-based obturations in root canal retreatment and to identify potential prognostic factors for healing.
Objectives:
- To determine the success rate of calcium silicate sealer-based obturations in root canal retreatment.
- To compare the observed outcomes with previously published retreatment studies using conventional obturation techniques.
- To identify potential prognostic factors associated with favourable or unfavourable outcomes.
This will be a prospective cohort study conducted at Jaber Al-Ahmed Dental Center. Informed written consent will be obtained from all participants. All nonsurgical root canal retreatments will be performed by a specialist endodontist using a calcium silicate-based sealer (CeraSeal, Meta Biomed) following current evidence-based standards. Treatments will be recorded in a secure database, and all cases will be followed for a minimum of 12 months.
Clinical and radiographic records will be reviewed, and eligibility will be determined according to predefined inclusion and exclusion criteria. All patient data will be anonymized before extraction and analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 是
入选标准
- •Participants must be 18-65 years of age at the time of recruitment
- •Participants must have a classification of I or II on the American Society of Anesthesiologists (ASA) physical status classification system
- •Participants must not have known allergies to any materials used in the study
- •Participants must agree to participate in the study by signing a consent form
- •Participants must have good oral hygiene
- •All types of permanent teeth that require root canal retreatment are included (incisors, canines, premolars & molars)
- •The teeth must be restorable and have fully formed roots with no advanced periodontal disease
排除标准
- •ASA classification of III or more
- •Pregnant or breastfeeding women
- •Patients who are unable to give consent
- •Patients who have advanced periodontal disease or teeth with more than 5mm probing
- •Teeth with incomplete root formation
- •Teeth that have a poor restorative prognosis
- •Teeth presenting with signs of a vertical root fracture
- •Teeth with blocked or non-negotiable canals
- •Teeth with broken instruments
- •Teeth with iatrogenic perforations
- •Teeth requiring posts or extensive prosthetic rehabilitation
- •Teeth with cracks
- •Teeth with internal or external root resorption
- •Teeth with uncontrollable exudate
结局指标
主要结局
Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)
时间窗: Comparison of periapical lesion size at baseline and 12 months
Estrela's PAI based on CBCT will be used in logistic regression models with different predictor variables.
Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms
时间窗: Comparison at baseline and 12 months
The examiner will label the teeth as having a normal clinical outcome (absence of pain, swelling and other symptoms, no sinus tract, no loss of function) or showing signs and symptoms clinical outcome (the tooth is associated with signs and/or symptoms of infection).
次要结局
未报告次要终点
研究者
Ahmed Aldowaisan
Principal Investigator, Specialist in Endodontics
Ministry of Health, Kuwait