跳至主要内容
临床试验/NCT07701200
NCT07701200已完成不适用

Patient Satisfaction and Prosthetic Complication of OT-Bridge System Versus Multiunit Abutment for Mandibular All On-4 Screw Retained Prostheses.

Mansoura University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月13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
20
试验地点
1
主要终点
Patient Satisfaction

研究概览

简要总结

This study aims to compare two different prosthetic systems used in mandibular full-arch implant-supported fixed prostheses (All-on-4). The study evaluates patient satisfaction and prosthetic complications associated with the OT-Bridge system versus multiunit abutments.

A total of 20 patients will be included and divided into two equal groups. All patients will receive implant-supported screw-retained fixed prostheses.

Clinical and prosthetic outcomes will be assessed at baseline (T0), 6 months (T6), and 12 months (T12), including evaluation of patient satisfaction and any prosthetic complications.

The findings of this study may help improve the selection of prosthetic systems to enhance clinical outcomes and patient quality of life.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult patients (≥18 years) with edentulous mandible.
  • •Patients receiving or having received All-on-4 dental implants in the mandible.
  • •Adequate implant stability to support prosthetic loading.
  • •Patients indicated for screw-retained full-arch fixed prostheses using either OT-Bridge system or multiunit abutments.
  • •Patients willing to participate and attend follow-up visits at T0, T6, and T12 months.

排除标准

  • •Patients with uncontrolled systemic conditions affecting healing (e.g., uncontrolled diabetes).
  • •Patients with failed or mobile implants.
  • •Severe parafunctional habits (e.g., uncontrolled bruxism).
  • •Poor oral hygiene compliance.
  • •Patients unable to attend follow-up visits

研究组 & 干预措施

Multiunit Abutment Group

Active Comparator

Patients receiving multiunit abutments in mandibular All-on-4

干预措施: Multiunit (Device)

OT- Bridge System

Experimental

Patients receiving OT-Bridge prosthetic system in mandibular All-on-4

干预措施: OT-Bridge (Device)

结局指标

主要结局

Patient Satisfaction

时间窗: Baseline, 6 months, 12 months

Patient satisfaction will be assessed using a structured questionnaire for patients receiving mandibular All-on-4 implant-supported fixed prostheses. Satisfaction will be evaluated at baseline (T0), 6 months (T6), and 12 months (T12) after prosthesis delivery, comparing OT-Bridge system and multiunit abutments.

Prosthetic Complications

时间窗: Baseline, 6 months, 12 months

Prosthetic complications will be recorded for both groups, including screw loosening, prosthesis fracture, loss of retention, and need for maintenance or adjustment. Evaluations will be performed at T0, T6, and T12 months in mandibular All-on-4 implant-supported prostheses.

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

Hanan Adel Ghazi

dentist

Mansoura University

研究点 (1)

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