Influence of Cementation Technique on Microstrain in Three-Unit Bridges on Ti-Bases Evaluated by Strain Gauges
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Peri-implant microstrain (µε) measured by strain gauges
研究概览
简要总结
This prospective clinical study compares two cementation techniques for implant-supported zirconia fixed partial dentures on titanium bases (Ti-bases): extraoral cementation performed on the working model and intraoral cementation performed chairside. Thirty clinical cases with two osseointegrated implants requiring a multi-unit zirconia restoration will be recruited at the UIC Dental Clinic. For each case, two restorations with identical design will be produced: one will be cemented extraorally (control) and an identical replica will be cemented intraorally (test). Micro-deformation will be assessed as peri-implant microstrain (µε) using a standardized strain-gauge setup and the same recording protocol for both techniques. The primary analysis compares microstrain between intraoral and extraoral cementation within each case; implant/prosthetic events will be recorded descriptively.
详细描述
This study will evaluate whether the cementation approach of zirconia restorations onto Ti-bases influences peri-implant strain. Two clinical workflows are compared: (1) extraoral cementation of the zirconia restoration to Ti-bases on the working model prior to delivery, and (2) intraoral chairside cementation of an equivalent restoration to Ti-bases using the same intended clinical seating conditions.
For each enrolled case, two restorations with the same design will be fabricated so that both cementation approaches can be assessed within the same case. After cementation, restorations will be evaluated using a standardized strain-gauge measurement setup on a model reproducing the clinical implant relationship, applying the same torque and recording procedure for both techniques.
All clinical procedures will be performed at the UIC Dental Clinic, and strain-gauge recordings will be performed at the collaborating center (Universidad Europea Miguel de Cervantes, UEMC) following a consistent protocol. Data will be handled using study codes, and only study-coded technical files will be shared with the collaborating center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
Blinding was not feasible. The evaluator knows which condition is being assessed because the extraoral (laboratory) cementation is evaluated first and the intraoral (chairside) cementation is evaluated afterwards; the two conditions are not assessed at the same time. To reduce bias, the same standardized strain-gauge setup and recording protocol are used for both measurements.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years old) in good general health.
- •Presence of an edentulous space requiring rehabilitation with a three-unit implant-supported fixed bridge.
- •Presence of two already osseointegrated Essential Cone implants (Klockner) indicated for a three-unit implant-supported restoration in the edentulous area.
- •Ability and willingness to participate and attend study visits and follow-up.
- •Signed informed consent.
排除标准
- •ASA III or ASA IV.
- •Current or previous treatment with bisphosphonates.
- •Smoking >10 cigarettes/day.
- •Extraction in the study area <3 months before implant placement with incomplete healing.
- •Guided bone regeneration in the study area with <6 months of healing time.
- •Signs of active periodontal disease (e.g., poor plaque control and/or bleeding on probing above acceptable levels).
研究组 & 干预措施
Extraoral cementation (laboratory)
Three-unit zirconia bridge cemented to Ti-bases extraorally on the working model under standardized laboratory conditions. Strain-gauge evaluation is performed in the laboratory prior to prosthesis delivery.
干预措施: Extraoral cementation on Ti-bases (Procedure)
Intraoral cementation (chairside)
An identical three-unit zirconia bridge is cemented to Ti-bases intraorally following a standardized chairside protocol. The assembly is then removed and sent to the laboratory. Strain-gauge evaluation is performed approximately 1 week after intraoral cementation (7 ± 3 days).
干预措施: Intraoral cementation on Ti-bases (Procedure)
结局指标
主要结局
Peri-implant microstrain (µε) measured by strain gauges
时间窗: Pre-delivery (laboratory assessment) and ~1 week after intraoral cementation (7 ± 3 days).
Micro-deformation around implant replicas supporting a three-unit zirconia bridge on Ti-bases, recorded with bonded strain gauges and expressed as microstrain (µε). Measurements are obtained for both cementation techniques (extraoral vs intraoral) using the same standardized recording protocol. Measurements for the extraoral (control) restoration are recorded prior to delivery, and measurements for the intraoral (test) restoration are recorded approximately 1 week after chairside cementation once the restoration is received by the laboratory.
次要结局
- Difference in microstrain between techniques (paired within-case)(Pre-delivery (laboratory assessment) and ~1 week after intraoral cementation (7 ± 3 days).)
研究者
Marta Vallés Rodríguez
DDS, phD
Universitat Internacional de Catalunya