Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients with Compromised Ridge: a Study of Patient Satisfaction and Oral Health Related Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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 within-patient study aimed to compare the satisfaction and oral health-related quality of life (OHRQoL) of edentulous maxillectomy patients with and without immediately loaded implant-supported obturator prostheses using single-piece compressive implants.
详细描述
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Inclusion criteria:
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Patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla.
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Residual alveolar ridge quantity and quality as verified by cone beam computed tomography (CBCT), especially in the proposed implant sites.
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Exclusion Criteria:
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Patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis.
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Radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6 months)
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Patients with local inflammation that may cause interference with implant placement.
All patients were informed about the detailed treatment plan and received a written informed consent to be signed.
II) Preparation of the patient for implant placement:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla.
- •Residual alveolar ridge quantity and quality will be verified by cone beam computed tomography (CBCT) especially in the proposed implant sites.
排除标准
- •Patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis.
- •Radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6-months)
- •Patients with local inflammation that may cause interference with implant placement.
研究组 & 干预措施
Conventional maxillary obturator
conventional acrylic obturator for each patient
干预措施: Maxillary obturator (Other)
Implant supported maxillary obturator
Implant-supported maxillary obturator (compressive implants)
干预措施: Implant supported obturator (Other)
结局指标
主要结局
Patient Satisfaction
时间窗: 6 months
Patient Satisfaction Based on Visual Analog Scale The patients were asked to rate their overall satisfaction with the dentures on a 100-mm visual analogue scale (VAS) for each type of prosthesis. The anchor of the left end of the VAS was defined as 'completely dissatisfied' and that of the opposite side as 'completely satisfied'
次要结局
- Oral health impact profile for edentulous patient (OHIP-EDENT)(6 months)
- - Obturator Functioning Scale(6 months)