Evaluation of Calcium and Phosphate Releasing Hybrid Restorative Material and Fluoride Releasing Hybrid Restorative Material Versus the Conventional Resin Composite in Proximal Carious Lesions Over One Year Follow-up Using USPHS Criteria
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 主要终点
- Mechanical evaluation according to USPHS criteria
研究概览
简要总结
Esthetic and mechanical evaluation of calcium and phosphate releasing hybrid restorative material and fluoride releasing hybrid restorative material versus the conventional nanofilled resin composite in proximal carious lesions over 1 year follow-up according to the USPHS criteria.
详细描述
3 groups of 45 patients will receive class II restorations by using calcium and phosphate releasing hybrid restorative material (Activa Presto), fluoride releasing hybrid restorative material (Giomer), and conventional nanofilled resin composite. Then these restorations evaluated at 24 hours after placement, 1 month, 3 months, 6 months and 12 months according the modified USPHS criteria in terms of fracture, marginal adaptation, retention, anatomic form, marginal discoloration, surface texture, and color match.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 40 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 clinics listed above.
- •Patients can tolerate necessary restorative procedures.
- •Provide informed consent.
- •Patients accept the one year follow-up period.
- •Patients are within middle age group (25-40years).
- •Cooperative patients.
- •Patients don't have any medically compromised conditions.
- •Tooth related criteria:
- •Teeth with primary proximal carious lesions in posterior teeth with no pulpal involvement.
- •Teeth should have contact with the adjacent teeth.
- •Teeth are vital according to pulp-sensitivity tests.
- •No active gingival or periodontal conditions.
排除标准
- •• Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
- •Pregnant women; as radiographs are prohibited.
- •Allergic Patients to any of the restorative materials, including anesthetics.
- •Uncooperative patients will not follow the instructions or attend the appointments.
- •Tooth related criteria:
- •Retained deciduous teeth; as the research 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) indicating irreversible pulpitis.
- •Negative sensitivity tests, periapical radiolucencies, and sensitivity to axial or lateral percussion indicating 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.
结局指标
主要结局
Mechanical evaluation according to USPHS criteria
时间窗: 1 year
Fracture, Retention, Marginal adaptation, Anatomic form, and Surface roughness
次要结局
- : Esthetic evaluation according to USPHS criteria. : Esthetic evaluation according to USPHS criteria. Esthetic evaluation according to USPHS criteria(1 year)
研究者
Nouran Osama El-Sayed Ahmed Abou El-Nour
Resident at Faculty of Dentistry
Cairo University