Evaluation of Masticatory Performance and Patient Satisfaction for Conventional and 3D Printed Implant Overdentures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Chewing efficiency
研究概览
简要总结
The aim of this crossover clinical study was the evaluation and comparison of masticatory performance and patient satisfaction for patients rehabilitated with conventional heat cured acrylic resin and 3D printed mandibular implant overdentures retained with bar attachment.
it was concluded that 3D printed implant overdenture showed promising results regarding chewing efficiency and patient satisfaction compared to conventionally fabricated implant overdenture.
详细描述
The aim of this crossover clinical study was the evaluation and comparison of masticatory performance and patient satisfaction for patients rehabilitated with conventional heat cured acrylic resin and 3D printed mandibular implant overdentures retained with bar attachment.
Materials and Methods
Twelve completely edentulous healthy participants received new conventional dentures. Four interforaminal implants were inserted in the mandible. After osseointegration, bar was constructed with trapezoidal configuration. Each patient received randomly the following overdentures using a crossover design: conventional heat cured acrylic resin overdenture, 3d printed overdenture ( developed by scanning of mandibular conventional overdenture). Masticatory performance was evaluated with the two-colour mixing ability test after 5, 10, 20, 30, and 50 masticatory cycles. Patient satisfaction was also measured using McGill Denture Satisfaction Questionnaire. Evaluation was done after 3 months of using each overdenture.
Conclusion: Within this clinical study limitations, 3D printed implant overdenture showed promising results regarding chewing efficiency and patient satisfaction compared to conventionally fabricated implant overdenture.
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 (Investigator)
盲法说明
The succession of complete denture insertion was randomized to diminish the effect of the order of complete denture use on the results.
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
- 是
入选标准
- •adequate bone quantity [classes 1-3 according to [Lekholm and Zarb] of the mandible in the lateral incisor and first premolar regions to receive 4 implants
- •adequate restorative space [12-15 mm from the mucosa of the mandibular ridge to the occlusal plane- Class I according to Ahuja and Cagna 23 for bar supported implant overdenture. This was verified by direct measurement of old denture
- •Angel's class I maxillo-mandibular relationship.
排除标准
- •include systemic diseases that contraindicate implant placement
- •irradiation of the head and neck region
- •chemotherapy within the past 3 years
- •bone metabolic diseases as uncontrolled diabetes mellitus
- •smoking habit
结局指标
主要结局
Chewing efficiency
时间窗: at time of insertion of prosthesis T(0), 3 months after insertion T(3).
Chewing efficiency was assessed using the previously documented two-color mixing ability test (colorimetric method) as follow: Two samples were prepared from two colored chewing gums. Patients were asked to keep the gum sample intraorally for one minute then start to chew it for 5, 10, 20, 30 and 50 strokes respectively. Five samples were used for the tests, the samples were spat into clear plastic bags. All samples were evaluated after flattening to wafers of 1 mm thickness. scanned by Digital scanner from both sides stored in Adobe Photoshop® format (psd). Then the color range tool and histogram function were used to pick out the unmixed white parts of the image. Then the ratio of Unmixed Fraction (UF) was computed using the following formula: (Pixels white side a + Pixels white side b) - 2× Pixels of scale / 2 × Pixels all. As a reference scale, a scanned piece of unmixed gum was copied in each image
Patient satisfaction
时间窗: at time of insertion of prosthesis T(0), 3 months after insertion T(3).
The eight core of McGill Denture Satisfaction Questionnaire (MDSQ) items were used to record patient satisfaction with their mandibular complete removable denture. One question concerns overall satisfaction with existing prostheses, whereas the other seven questions refer to specific aspects that may influence overall satisfaction: ease of cleaning; ability to speak; comfort; aesthetics/appearance; and denture stability; chewing ability; chewing function. Respondents provided answers on a 100-mm visual analogue scale. Patients were encouraged to respond to the survey questionnaire after functioning with each type of denture for 3-months.
次要结局
未报告次要终点
研究者
Mohamed shady
Assistant Professor
Mansoura University