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临床试验/NCT06401187
NCT06401187已完成不适用

Evaluation of Patient Satisfaction and Maximum Biting Force of Three Different Constructed Bars in Implant Overdenture in One Year Follow-up

Minia University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Patient Satisfaction

研究概览

简要总结

Statement of problem. Patient satisfaction and maximum biting force from patients who wear 2-implant-retained overdentures with different constructed bar attachments can be improved.

Purpose. This randomised controlled clinical trial assessed patient satisfaction and maximum biting force with three differently constructed bar-retained overdentures (conventional casting, Milling and 3D printing CAD/CAM techniques) within a one-year follow-up.

Material and methods. A total of 60 implants were placed in 30 mandibular jaws(30 participants). The jaws were randomly assigned to 1 of the 3 treatment groups: a 10 conventional technique cast Co-Cr bar attachment, a 10 Co-Cr CAD/CAM milled bar attachment, and a 10 Co-Cr CAD/CAM 3D-printed bar attachment all groups were connected to 2 implants in the canine area. Patient satisfaction was tested after 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and the Kruskal-Wallis test. Maximum biting force was tested at baseline,3 months, 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and ANOVA test.

详细描述

A total of 60 implants were placed in 30 mandibular jaws(30 participants). The jaws were randomly assigned to 1 of the 3 treatment groups: a 10 conventional technique cast Co-Cr bar attachment, a 10 Co-Cr CAD/CAM milled bar attachment, and a 10 Co-Cr CAD/CAM 3D-printed bar attachment all groups were connected to 2 implants in the canine area. Patient satisfaction was tested after 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and the Kruskal-Wallis test. Maximum biting force was tested at baseline,3 months, 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and ANOVA test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with sufficient residual alveolar bone quantity and quality anterior to the mental foramen to receive self-taping root form titanium implants.
  • •Maxillary and Mandibular residual alveolar ridges covered with healthy mucosa without any remaining roots or local inflammation.
  • •Patients with sufficient inter-arch space (at least 15 mm) to have overdenture and bar attachment.
  • •U-shaped lower ridge to avoid the lingual placement of the bar that occurs with a V-shaped ridge.
  • •Patients with skeletal and dental class I.

排除标准

  • •Patients with systemic diseases such as cardiovascular diseases, any disease of immunity, febrile conditions such as epilepsy, metabolic disorders, osteoporosis, hyperparathyroidism, and impaired psychological conditions that might affect the oral tissues or the bone metabolic rate.
  • •Patients with local and general contraindications for surgical procedures.
  • •Patients with TMJ or neuromuscular disorder.
  • •Patients with Para functional habits such as bruxism and clenching.
  • •Patients with impacted teeth or remaining roots.
  • •Alcoholic patients.
  • •Patients with a history of radiotherapy in the head and neck region.
  • •Non-cooperative patients.
  • •Patients with a history of bisphosphonate intake.
  • •Patients with flabby tissues, bony undercuts, sharp bony edges, thin ridges or abnormalities at the lower alveolar ridge and recent extraction.

研究组 & 干预措施

Co-Cr conventional technique cast bar attachments

Active Comparator

conventional technique cast bar attachments

干预措施: Bar overdenture (Other)

Co-Cr CAD/CAM milled bar attachments

Experimental

Co-Cr CAD/CAM milled bar attachments

干预措施: Bar overdenture (Other)

Co-Cr CAD/CAM 3D bar attachments

Experimental

Co-Cr CAD/CAM 3D bar attachments

干预措施: Bar overdenture (Other)

结局指标

主要结局

Patient Satisfaction

时间窗: 1 year

questionnaire

次要结局

  • maximum biting force(1 year)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

mona nabawy

lecturer assistant

Minia University

研究点 (1)

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