Outcome of Sealer-Based Obturation With AH Plus Bioceramic Sealer Versus Warm Vertical Compaction With AH Plus: A CBCT-Based Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy and outcome of sealer-based obturation (SBO) using a new calcium silicate sealer in comparison with warm vertical compaction (WVC) using a resin-based sealer, which is the current gold standard.
详细描述
Calcium silicate sealers are used in endodontics because of their biocompatibility, bioactivity, and their ability to form a hydroxyapatite-mediated interfacial bond with root canal dentine. Although in vitro and retrospective clinical studies have reported promising findings, there remains a lack of prospective, well-controlled trials evaluating their clinical and radiographic performance.
Aims and Objectives:
- To compare the clinical outcome of single-cone bioceramic obturation (SBO) with warm vertical compaction (WVC) in primary root canal treatment.
- To compare the radiographic outcome of SBO and WVC using periapical (PA) radiographs and cone-beam computed tomography (CBCT).
Materials and Methods:
Patients referred for primary root canal treatment of molar teeth at Jaber Al-Ahmed Dental Center who fulfil the inclusion and exclusion criteria will be invited to participate. Written informed consent will be obtained from all participants.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be blinded to the type of treatment they will receive to reduce bias in the reporting of pain.
Since it is not possible to blind the care providers, they will only be informed of the type of treatment once cleaning and shaping has been completed and the tooth is ready to be obturated. This will reduce care provider bias.
Assessors will be blinded to the treatment option to reduce bias during the assessment of healing.
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
- •Maxillary and mandibular permanent molar teeth that require primary root canal treatment will be included
- •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
- •Anterior, premolar and third molar teeth
- •Teeth whose apices were over-enlarged at the time of pulp extirpation
- •Teeth with broken instruments
- •Teeth with blocked or non-negotiable canals
- •Teeth with iatrogenic perforations
- •Teeth with incomplete root formation
- •Teeth with internal or external root resorption
- •Teeth that have a poor restorative prognosis
- •Teeth that require posts or extensive prosthetic rehabilitation
- •Teeth with cracks
- •Teeth that have been previously root-filled
研究组 & 干预措施
SBO with AH Plus Bioceramic Sealer
The teeth will be obturated using a single cone technique with AH Plus Bioceramic Sealer.
干预措施: AH Plus Bioceramic Sealer (Device)
WVC with resin-based AH Plus Sealer
The teeth will be obturated using warm vertical compaction with resin-based AH Plus Sealer.
干预措施: AH Plus Sealer (resin-based) (Device)
结局指标
主要结局
Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms
时间窗: Change from baseline at 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).
Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)
时间窗: Change from baseline periapical lesion size at 12 months
Estrela's PAI based on CBCT will be used in logistic regression models with different predictor variables.
Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)
时间窗: Change from baseline periapical lesion size at 12-24 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: Change from baseline at 12-24 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