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临床试验/NCT07400380
NCT07400380已完成不适用

Prosthetic Complications and Patient Satisfaction of Two Different Implant Distribution for Stress Free Implant Bar Mandibular Overdenture:

Mansoura University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
patient satisfaction

研究概览

简要总结

Purpose: This clinical study aimed to evaluate patient satisfaction and prosthetic complications of different distributions of four implants supported mandibular overdentures using Stress free implant bar (SFI-Bar attachments). Evaluation was done for patient satisfaction and prosthetic complications

详细描述

Purpose: This clinical study aimed to evaluate patient satisfaction and prosthetic complications of different distributions of four implants supported mandibular overdentures using Stress free implant bar (SFI-Bar attachments). Materials and Methods: thirty completely edentulous patients with insufficient retention and stability of their conventional mandibular denture were eligible for this study. All patients received new maxillary and mandibular dentures. The patients were randomly divided into three groups. (G1): four implants were distributed in interforaminal distance, 2-Implant were inserted in canine region and 2- implant 8mm posterior to canine implants. (G2): 4-implants were distributed in quadrilateral distribution, 2-Implant in canine region and 2-Implant were inserted 26mm posterior to canine implant. Patient satisfaction was evaluated by visual analogue scale and prosthetic complications were evaluated on the patient level and implant patients.

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 (Participant)

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

入选标准

  • Normal jaw relation Good oral hygiene Patient with class I or class II inter-rach space.

排除标准

  • Patients with TMJ disorder and heavy smokers for more than 10 cigarettes per day.
  • Uncooperative patient. Unfavorable occlusion. Limited restoration space (less than 12 mm).

研究组 & 干预措施

quadrilateral group

Other

4-implants were distributed in quadrilateral distribution, 2-Implant in canine region and 2-Implant were inserted 26mm posterior to canine implant.

干预措施: four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted (Procedure)

curved group

Other

Receive four implants distributed in interforaminal distance, 2-Implant were inserted in canine region and 2- implant 8mm posterior to canine implants.

干预措施: four implants inserted in the mandible and distributed in quadrilateral manner and SFI-Bar had been inserted (Procedure)

结局指标

主要结局

patient satisfaction

时间窗: one year

A visual analog scale (VAS) and oral health-related quality of life (OHRQoL) were used for evaluating patient satisfaction. Participants in the VAS were instructed to draw a vertical line anywhere along a horizontal line that was used as a scale, with 0 mm representing the worst and 100 mm representing the best. at the point that most accurately reflected their perceptions. General satisfaction, denture stability and retention, occlusion, comfort, ease of cleaning, ease of speaking, ease of chewing, bolus quality, and aesthetics

次要结局

  • prosthetic complications(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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