Restorative Comparison of Facebow and Simplified Techniques for Digital Jaw Relation Records in Treatment of Occlusal Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Adjustment Time for Restoration
研究概览
简要总结
Accurate recording of the intermaxillary relationship is crucial for achieving successful restorative outcomes.
In cases of occlusal support loss, determining and recording the intermaxillary relationship becomes more complex.
This study aims to compare the occlusal compatibility of restorations fabricated using either an intraoral scanner or a jaw motion tracking and analysis device for recording the intermaxillary relationship in patients with occlusal support loss.
详细描述
This study is designed to fabricate bilateral fixed prosthetic restorations in the maxillary posterior region and to evaluate the clinical success, efficiency, and patient satisfaction associated with different intermaxillary relationship recording methods.
The study will compare the clinical outcomes of restorations produced using two techniques:
Group I: Centric relation (CR) determined by bimanual manipulation and recorded with an intraoral scanner.
Group II: Centric relation (CR) determined by neuromuscular deprogramming and recorded with a jaw movement/tracking analysis device.
All tooth preparations will follow standard preparation principles, ensuring minimum material thickness. Preparations will be completed by the investigator (ESK). After preparation, intraoral scans of the upper and lower jaws will be obtained using an intraoral scanner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary participation after reading and understanding the informed consent form.
- •Age between 18 and 65 years with completed growth and development.
- •Healthy dental and periodontal condition.
- •Presence of bilateral edentulism in the maxillary posterior region leading to occlusal support loss, requiring fixed prosthetic treatment.
- •Fixed dentition present in the mandible.
排除标准
- •Refusal to voluntarily participate after reading the informed consent form.
- •General health condition unsuitable for prosthetic treatment.
- •Use of removable prostheses in the mandibular arch.
- •Presence of temporomandibular joint dysfunction, orofacial pain, or acute oral disease.
- •Presence of a pacemaker or implantable defibrillator.
研究组 & 干预措施
Determination of Intermaxillary Relationship in Patients with Posterior Support Loss
For each participant, an intraoral scan was initially obtained using the bimanual manipulation method to determine the centric relation. Subsequently, the neuromuscular deprogramming method was applied, and recordings were obtained using a jaw movement tracking and analysis device.
During occlusal adjustment of the restorations fabricated based on both recording methods, the following parameters were evaluated: occlusal surface adaptation, adjustment time, and number of articulating paper applications.
干预措施: Fixed prosthesis with bimanual CR and intraoral scan (Procedure)
结局指标
主要结局
Adjustment Time for Restoration
时间窗: 1 year
The time required to adjust the restoration will be recorded in minutes and scored on a 0-4 scale as follows: 0 (≤1 min), 1 (1-5 min), 2 (5-10 min), 3 (10-15 min), 4 (≥15 min).
Adjusted Surface Area of the Restoration
时间窗: 1 year
The surface area requiring adjustment will be measured in square millimeters (mm²) using ImageJ software and scored from 0 to 4: 0 (≤1 mm²), 1 (1-6 mm²), 2 (6-10 mm²), 3 (10-15 mm²), 4 (≥15 mm²).
Number of Articulation Paper Uses
时间窗: 1 year
The number of articulation paper uses will be counted and scored from 0 to 4 as follows: 0 (2-4 uses), 1 (5-7), 2 (8-10), 3 (10-13), 4 (≥14 uses).
Composite Clinical Success Score of the Restoration
时间窗: 1 year
The clinical success of each restoration will be evaluated using a composite score derived from three parameters: Adjustment Time, Adjusted Surface Area,Number of Articulation Paper Uses. Each parameter is scored from 0 to 4, yielding a total score between 0 and 12. Based on the total score, restorations will be categorized as follows: Excellent (Score 0-1): Restoration has a clinically optimal fit. Occlusal contacts are properly and evenly distributed. Successful (Score 2-4): Restoration shows good clinical fit with minor occlusal adjustments. Moderate (Score 5-7): Restoration is clinically acceptable with occlusal adjustments. Weak (Score 8-10): Restoration has issues in clinical fit and required major occlusal adjustments. Unsuccessful (Score 11-12): Clinical fit is unacceptable. Adjustments caused morphological distortion or resulted in occlusal gaps. Restoration must be replaced. This composite score will serve as the primary measure of overall clinical success.
次要结局
- Occlusal Comfort Evaluated Using Visual Analog Scale(1 year)
研究者
Kıvanç Akça
Professor, Department of Prosthodontics
Hacettepe University