Clinical Evaluation of Fiber Reinforced Bulk Fill Resin Composite Versus Incremental Packing of Nanohybrid Resin Composite in Restoration of Deep Proximal Lesions of Permanent Posterior Molars: A Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Mechanical outcome according to USPHS criteria
研究概览
简要总结
A clinical trial, comparing two different incrementation techniques in the restoration of proximal caries in permanent posterior teeth . One utilizes a fiber reinforced bulk fill base material, followed by an occlusal nanohybrid capping layer. The other utilizes incremental packing of nanohybrid resin composite material to fill the whole cavity.
详细描述
The aim of this study is to conduct an RCT to evaluate the clinical performance of the fiber reinforced bulk fill resin composite in comparison to incremental packing of nanohybrid resin composite.
Examination and selection of all patients will be done according to inclusion and exclusion criteria. Diagnosis of patients' chief complaint and teeth that will be involved in this study will be done. Teeth are to be chosen according to standardized radiographic examination. Teeth should have proximal, primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber.
A Class II cavity will be prepared after local anesthesia has been given as required. The cavity will be prepared using a high-speed hand-piece with air and water coolant and diamond burs of different sizes. Sharp excavators will allow accessible removal of soft carious lesions will be used. Any tooth that will suffer from pulpal exposure will be excluded from the study. Finishing of the cavity walls will be done using a fine-grit, yellow coded, diamond bur.
Rubber dam isolation will be done.
Sectional matricing and wedging will be done. Followed by, placement of restorative material according to the randomization sequence.
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient-related criteria:
- •Patients consulting in one of the outpatient clinic listed above.
- •Able to tolerate necessary restorative procedures.
- •Provide informed consent.
- •Accepts the one year follow-up period.
- •Tooth related criteria:
- •Teeth with primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber.
- •Teeth are vital according to pulp-sensitivity tests.
排除标准
- •Patient-related criteria:
- •Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
- •Pregnant women; as radiographs cannot be taken for them.
- •Allergy to any of the restorative materials, including anesthetics.
- •Uncooperative patients, will not abide by the instructions or attend the appointments.
- •Tooth related criteria:
- •Deciduous teeth; as the study is targeting only permanent teeth.
- •Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
- •Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests), which would indicate irreversible pulpal damage.
- •Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion, which would indicate pulp necrosis.
- •Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.
- •Teeth with cervical caries; which can't be evaluated on periapical radiographs
研究组 & 干预措施
Fiber Reinforced bulk fill resin composite
Fiber reinforced bulk fill resin composite dentine substitute, capped occlusally and proximally (closed centripetal technique) by nanohybrid resin composite.
干预措施: EverX Posterior (Drug)
nanohybrid resin composite incrementation
Nanohybrid resin composite layering to fill the whole cavity, using closed centripetal technique.
干预措施: Resins, Composite (Drug)
结局指标
主要结局
Mechanical outcome according to USPHS criteria
时间窗: 12 months
fracture or retention, marginal integrity, marginal discoloration, anatomic form, proximal contact, radiographic examination and surface texture
次要结局
- Biological outcome according to USPHS criteria(12 months)
研究者
Mennatallah Salem
Assistant Lecturer
Cairo University