Clinical Performance of a Self-Cure Composite System Versus a Highly Filled Flowable Composite System in Carious Cervical Lesions: A Randomized 18 Months Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
The aim of the study is to compare and evaluate the clinical performance of a self cure composite system versus a highly filled flowable composite in the restoration of carious cervical lesions over an 18 months follow up period.
详细描述
Examination and selection of patients will be done according to the inclusion and exclusion criteria. A class V cavity will be prepared after local anesthesia has been given. Followed by the placement of the restorative material according to the randomization sequence.
For the intervention: the primer will be applied first followed by filling of the cavity using self cure composite (Stella Automix or Stela Capsule, SDI Ltd, Australia). For the control group: etching of the cavity (Kulzer Gluma Etch, Kulzer GmbH, Germany) will be done followed by rinsing, drying, applying the bonding agent (Solobond M, Voco GmbH, Germany), curing, and lastly, applying the highly filled flowable composite (Polofil NHT flow, Voco Gmbh, Germany) and curing.
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
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient-related Criteria:
- •A) Inclusion Criteria:
- •Patients consulting in the outpatient clinic with cervical carious lesion.
- •Age between 21-45 years.
- •Males and females.
排除标准
- •Systemic disease or severe medical complication.
- •Allergy to any of the restorative materials.
- •Pregnancy.
- •Disabilities.
- •Heavy smoking; xerostomia.
- •Lack of compliance.
- •Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits.
- •Tooth-related Criteria:
- •A) Inclusion Criteria:
- •Small to moderate class V carious lesion.
- •Teeth are vital with no signs of irreversible pulpitis.
- •Caries cervical margins above the CEJ.
- •Well-formed and fully erupted in normal functional occlusion with natural antagonist.
- •B) Exclusion Criteria:
- •Deciduous teeth; as the study is targeting only permanent teeth.
- •Deep carious defects (close to the pulp, less than 1 mm distance).
- •Tooth hypersensitivity.
- •Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
- •Heavy occlusion and occlusal contacts or history of bruxism.
- •Endodontically treated teeth.
- •Periapical pathology or signs of pulpal pathology.
研究者
Abdelrahman Hamza Halim Hamza
MSc Candidate, Department of Restorative and Esthetic Dentistry, Faculty of Dentistry, Cairo University
Cairo University