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临床试验/NCT04928274
NCT04928274已完成不适用

Evaluation of Bone Height Changes In Three Implants Retained Mandibular Overdenture Using Three Different Attachment Design. A Randomized Clinical Trial.

Kafrelsheikh University3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年1月1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
入组人数
24
试验地点
3
主要终点
Bone height measurement

研究概览

简要总结

this study was to compare the bone height changes around three implant telescopic, locator, and ball retained mandibular overdentures. radiographic changes in peri-implant tissue in three groups were evaluated

详细描述

Twenty-four completely edentulous patients were recruited from the outpatient clinic of Removable Prosthodontics Cairo University. All patients recruited were seeking to install implants in their lower jaw, and have to meet the following inclusion criteria: age ranging from 50 to 69 years old, patients should have no contra-indication for implant installation, all patients should perform a glycosylated hemoglobin analysis and only up to 8 were included in the study. All patients had to sign an informed consent before the start of the study, and have to comply with the assigned follow-ups. Patients with any contraindications for implant placement or those who didn't comply with the follow ups were excluded from the study.

All patients included had maxillary and mandibular complete dentures fabricated following the conventional steps, after a period of 6 weeks adaptation, all patients were ready for implant installation. The lower denture was duplicated into a radiographic stent, having radio-opaque markers in the areas of implant installation. All patients had a CBCT x ray wearing the radiographic stent, to allow for proper implant planning and to visualize the height and width of the osteotomy site. The radiographic stent was then modified to a surgical stent by making a tunnel corresponding to the site of implant installation. All Patients in this study received three implants in the lower jaw at the premolar-canine area bilaterally and one implant in the midline at the central incisor area.

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
Single (Outcomes Assessor)

盲法说明

Two blinded operators have carried out the assessment of bone height changes in order to have accurate results.

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age ranging from 50 to 69 years old, patients should have no contra-indication for implant installation, all patients should perform a glycosylated hemoglobin analysis and only up to 8 were included in the study

排除标准

  • •Patients with any contraindications for implant placement or those who didn't comply with the follow ups were excluded from the study.

研究组 & 干预措施

ball retained mandibular over denture

Other

each patient in this group received 3 implant installed in mandible and 3 ball attachments for retention of over denture

干预措施: ball attachment to retain mandibular over denture (Other)

locator retained mandibular over denture

Other

干预措施: locator attachment to retain mandibular over denture (Other)

telescopic retained mandibular over denture

Other

干预措施: telescopic attachment to retain mandibular over denture (Other)

结局指标

主要结局

Bone height measurement

时间窗: one year

The Digora software was then used to measure bone height changes on the mesial and distal surface of each implant. The Digora software was then used to measure bone height changes on the mesial and distal surface of each implant. The implant in the peri-apical x ray was calibrated by drawing a line from the junction of the implant and abutment to the apical end of the implant, this line was the calibration line corresponding to the implant real length which was 11.5mm. After the implant was calibrated, a line was drawn on each implant surface; at the mesial and distal surface starting from the first implant thread to bone contact to the apical implant thread to bone contact. The line drawn would correspond to the bone height on each surface . Two blinded operators have carried out the assessment of bone height changes in order to have accurate results.

次要结局

未报告次要终点

研究者

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

Nourhan Ahmed Ragheb

Lecturer , Prosthodontist, Department of Prosthodontics, Faculty of Oral & Dental Medicine,Kafr El-shiekh University, Kafr El-shiekh ,Egypt.

Kafrelsheikh University

研究点 (3)

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