The Outcome of Non-surgical Root Canal Treatment Using Sealer-based Obturation With Calcium Silicate Sealer vs. Warm Vertical Compaction With AH+ Sealer. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Assessment of radiographic healing with Cone beam computed tomography (CBCT) scans using Estrela's PAI based on CBCT
研究概览
简要总结
A single blinded randomized controlled trial. 212 subjects (teeth), 106 in each of the 2 groups will be recruited from the patients referred to Kuwait Board of Endodontics for primary root canal treatment. The aim is to compare the outcome of sealer-based obturation (SBO) with calcium silicate sealer versus warm vertical compaction (WVC) and resin based sealer.
Preoperative PA radiograph and CBCT will be taken. A 1 year follow up period will be arranged and another PA radiograph and CBCT will be taken. The preoperative, postoperative and review clinical and radiographic data will be analyzed
详细描述
Aims and Objectives
- To compare the clinical outcome of the SBO with WVC in non-surgical root canal treatment.
- To compare the radiographic outcome of the SBO with WVC in non-surgical root canal treatment using periapical radiographs and CBCT scans.
- To assess the difference in postoperative pain between the 2 groups.
- To assess the difference in the time required to complete the obturation between the 2 groups.
Materials and Methods
- Patients who are referred to the Kuwait Board of Endodontics for non-surgical root canal treatment and fulfil the inclusion/exclusion criteria of the study will be included
- Pre-operative periapical radiograph, CBCT scan and 11-point Numerical Rating Scale (NRS) will be taken.
- Upon completion of root canal instrumentation, the participants will be randomly allocated to either Group A: obturation using SCCS or Group B: obturation using WVC. The participants will be blinded to the type of treatment received and the clinician will only be informed of the obturation method once the canal/canals are ready for obturation.
- All teeth will then be restored definitively.
- The participants will be contacted via telephone 1, 3 and 7 days post-treatment to report their NRS pain score.
- The participants will be recalled after 1 year for clinical and radiographic assessment using periapical radiograph and CBCT scan.
- The participants will then be followed-up annually for up to 4 years.
- Statistical analysis will be performed.
- The design of the study will conform to the CONSORT statement.
Statistical and Analytical Plans
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 receive to reduce bias in the reporting of postoperative pain.
Since it is not possible to blind the care providers, they will only be informed of the type of treatment once full chemo-mechanical debridement has been completed and the tooth is ready to be obturated. This would 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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •All types of permanent teeth are included (incisors, canines, premolars & molars)
- •The teeth must be restorable and have fully formed roots with no advanced periodontal disease
- •In the event that a patient has more than 1 tooth eligible for the study, only one tooth on the left and/or right side of the mouth will be selected at random. A maximum of 2 teeth per participant can be included in the study
排除标准
- •ASA classification of III or more
- •Pregnant women
- •Advanced periodontal disease or teeth with more than 5mm probing
- •Teeth with incomplete root formation or root resorption
- •Teeth with adjacent teeth that require RCT
- •Previously root canal treated teeth
- •Teeth with a history of trauma
- •Teeth that have poor restorative prognosis
- •Teeth requiring extensive prosthodontic rehabilitation
- •Cracked teeth
结局指标
主要结局
Assessment of radiographic healing with Cone beam computed tomography (CBCT) scans using Estrela's PAI based on CBCT
时间窗: Comparison of of periapical lesion size at baseline and 12 months
Proportion t-test will be carried to compare the proportion of study subjects with improved apical lesion size between the two treatment groups. Odds ratio with 95% confidence interval will be reported. Logistic regression analysis adjusted for the stratification variables (gender) and other confounding factors (namely patency, extrusion of sealer or GP, short fill, voids, pre-op apical size, pre-op clinical symptoms and number of C\&S visits). Estrela's (periapical index) PAI based on CBCT will be used as outcome measure
Assessment of radiographic healing with periapical (PA) radiographs using Orstavik's PAI
时间窗: Comparison of of periapical lesion size at baseline and 12 months
Proportion t-test will be carried to compare the proportion of study subjects with improved apical lesion size between the two treatment groups. Odds ratio with 95% confidence interval will be reported. Logistic regression analysis adjusted for the stratification variables (gender) and other confounding factors (namely patency, extrusion of sealer or GP, short fill, voids, pre-op apical size, pre-op clinical symptoms and number of C\&S visits). Orstavik's periapical index (PAI) will be used as the outcome measure
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
- Comparison of the postoperative pain score(1, 3 and 7 days postoperatively)
- Comparison of the time required to complete obturation between the 2 groups(Intra-operatively)
研究者
Fahad Alzoubi
Chair of Faculty of Dentistry
Kuwait Institute for Medical Specialization