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临床试验/NCT07693946
NCT07693946招募中不适用

Jaw Tracking Impact on Occlusion and Patient Outcomes in Maxillary Implant Restorations: Randomized Clinical Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Patient Satisfaction

研究概览

简要总结

This randomized clinical trial aims to evaluate the effect of integrating digital jaw tracking into the workflow for fabrication of full-arch maxillary implant-supported screw-retained restorations. Twenty completely edentulous maxillary patients opposing natural mandibular dentition will be randomly assigned to either a conventional workflow group or a digital jaw-tracking workflow group. The study will compare patient satisfaction and occlusal accuracy between the two groups. Patient satisfaction will be assessed using a visual analogue scale (VAS), while occlusal accuracy will be evaluated using the OccluSense system.

详细描述

This randomized clinical trial will compare conventional prosthetic workflow with a digital jaw-tracking workflow for the fabrication of full-arch maxillary implant-supported screw-retained restorations.

Twenty edentulous patients with completely edentulous maxillary arches opposing natural mandibular dentition will be recruited and randomly allocated into two equal groups. Group A will receive restorations fabricated using the conventional workflow with static jaw relation records, while Group B will receive restorations fabricated using a digital workflow incorporating dynamic jaw tracking and a virtual articulator.

The primary outcome will be patient satisfaction, assessed using a visual analogue scale (VAS) after prosthesis insertion and during follow-up visits. Occlusal accuracy will be evaluated using the OccluSense digital occlusal analysis system. The study aims to determine whether digital jaw tracking improves occlusal accuracy and patient-reported outcomes compared with the conventional workflow.

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
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients aged 50 to 70 years.
  • Completely edentulous maxillary arch opposing natural mandibular dentition.
  • Skeletal Class I maxillomandibular relationship with normal occlusion.
  • Acceptable oral hygiene.
  • Willing and able to provide written informed consent and comply with study procedures.

排除标准

  • Systemic diseases affecting bone healing, such as uncontrolled diabetes mellitus or osteoporosis.
  • Harmful oral habits, including smoking, clenching, or bruxism.
  • Uncooperative patients or patients unable to comply with study procedures.

结局指标

主要结局

Patient Satisfaction

时间窗: At prosthesis insertion, 3 months, and 6 months after prosthesis insertion

Patient satisfaction will be assessed using a Visual Analogue Scale (VAS) to evaluate patient satisfaction with the implant-supported prosthesis regarding comfort, chewing ability, aesthetics, and phonetics.

次要结局

  • Occlusal Accuracy(At prosthesis insertion and 3 months after insertion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shahira Saad Abd ElKhabeer Mohamed Elsyed Ali

Clinical demonstrator at prosthodontics department

Mansoura University

研究点 (1)

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