The Performance of Posterior Partial Coverage Coronal Restorations Cemented Using Two Different Luting Systems. A Comparative Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Clinical evaluation of surface staining of posterior partial coverage ceramic restoration.
研究概览
简要总结
This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth. It will follow a split-mouth design with 60 participants selected based on strict criteria. Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria, evaluating retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness.
The null hypothesis:
The use of preheated resin composite for cementing partial coverage restoration will not result in significantly superior clinical performance when compared to that after using dual-cure resin cement.
详细描述
The adhesive cementation of ceramic partial coverage restorations is a technique-sensitive process essential for achieving optimal retention and marginal integrity. While dental resin cements are commonly used for adhesive luting of indirect ceramic restorations, concerns exist regarding their long-term reliability due to susceptibility to degradation over time and polymerization shrinkage-related issues.
This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth, aiming to address these drawbacks. It will follow a split-mouth design with 60 participants selected based on strict criteria. The preparation and delivery appointments follow specific guidelines, incorporating the Morphology Driven Preparation Technique (MDPT). Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria, evaluating retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness.
The objectives of this clinical trial are to evaluate the clinical performance of posterior partial coverage coronal restorations utilizing two different luting systems (preheated resin-based composite versus conventional dual-cure resin cement) in a split-mouth study design.
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)
盲法说明
The patients who participated in the study and the assessor of the treatment outcome do not know the type of treatment procedure received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consenting participants.
- •Individuals aged 18 years and above with no systemic diseases that will affect their participation.
- •Teeth of healthy periodontium.
- •Teeth to be restored in normal occlusion with natural antagonist and adjacent teeth.
- •Acceptable oral hygiene characterized by no gingivitis, calculus deposit or active carious lesions.
- •Non-vital teeth will be included
排除标准
- •Heavy occlusal contacts or signs of bruxism.
- •Profound, chronic periodontitis
- •Poor oral hygiene.
- •Sustained dentin hypersensitivity.
- •Systemic disease or severe medical complications or taking anti-inflammatory, analgesic, or psychotropic drugs.
研究组 & 干预措施
Preheated resin composite (IPS Empress Direct) group
Endodontically treated teeth will be prepared to receive partial coverage ceramic restorations that will be luted with preheated composite.
干预措施: IPS Empress Direct (Device)
Dual-cure adhesive resin cement (Bisco Duo-Link Universal) group
Endodontically treated teeth will be prepared to receive partial coverage ceramic restorations that will be luted with dual-cure adhesive resin cement.
干预措施: Bisco Duo-Link Universal (Device)
结局指标
主要结局
Clinical evaluation of surface staining of posterior partial coverage ceramic restoration.
时间窗: 1 year
Clinical examination and evaluation of the presence or absence of surface staining of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: staining absent Beta score means: staining present
Clinical evaluation of wear of posterior partial coverage ceramic restoration.
时间窗: 1 year
Clinical examination and evaluation of the wear presence or absence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: absence of wear. Beta score means: wear present.
Radiographic evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration.
时间窗: 1 year
Radiographic examination and evaluation of the adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta and Echo. Alpha score means: restoration contour is continuous with the existing anatomical margin of the tooth. Beta score means: restoration is slightly under or over contoured. Charlie score means: marginal overhang or tooth structure (dentin or enamel) is exposed. Delta score means: restoration is missing.
Clinical evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration.
时间窗: 1 year
Clinical examination and evaluation of the caries presence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: No visible caries Beta score means: caries present
Clinical evaluation of the performance of marginal adaptation of posterior partial coverage ceramic restoration.
时间窗: 1 year
Clinical examination and evaluation of the marginal adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta. Alpha score means: Excellent continuity at resin-enamel interface, no ledge formation, no discoloration Beta score means: Slight discoloration at resin-enamel interface; ledge at interafce. Charlie score means: Moderate discoloration at resin-enamel interface measuring 1mm or greater. Delta score means: Recurrent caries at margins.
Clinical evaluation of contact points of posterior partial coverage ceramic restoration.
时间窗: 1 year
Clinical examination and evaluation of the contact points quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: contact point present Beta score means: contact point absent.
Clinical evaluation of fracture of posterior partial coverage ceramic restoration.
时间窗: 1 year
Clinical examination and evaluation of the structural integrity endurance of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta, Echo. Alpha score means: No fracture of the restoration. Beta score means: Small chipping (1/4 of restoration) Charlie score means: Moderate chipping (1/2 of restoration) Delta score means: Severe chipping (3/4 of restoration) Echo score means: loss of the restoration.
Radiographic evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration.
时间窗: 1 year
Radiographic examination and evaluation of the caries presence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: No visible caries Beta score means: caries present
Clinical evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration.
时间窗: 1 year
Clinical examination and evaluation of the adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta and Echo. Alpha score means: restoration contour is continuous with the existing anatomical margin of the tooth. Beta score means: restoration is slightly under or over contoured. Charlie score means: marginal overhang or tooth structure (dentin or enamel) is exposed. Delta score means: restoration is missing, or traumatic occlusion, or restoration causes pain.
Radiographic evaluation of marginal adaptation of posterior partial coverage ceramic restoration.
时间窗: 1 year
Radiographic examination and evaluation of the marginal adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta. Alpha score means: Excellent continuity at resin-enamel interface, no ledge formation, no discoloration Beta score means: Slight discoloration at resin-enamel interface; ledge at interafce. Charlie score means: Moderate discoloration at resin-enamel interface measuring 1mm or greater. Delta score means: Recurrent caries at margins.
次要结局
未报告次要终点