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临床试验/NCT06721377
NCT06721377招募中不适用

Clinical and Radiographic Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年9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
招募中
入组人数
10
试验地点
1
主要终点
Radiographic evaluation of bone height

研究概览

简要总结

Patients will be selected from the outpatient clinic of Removable Prosthodontic Department. Faculty of Dental Medicine for Girls, Al-Azhar University..

Each patient will be assessed for eligibility and Informed consent will be obtained from patient after explanation of the treatment protocols and expected outcomes or alternative management.

详细描述

All 10 patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be divided into two groups, one group will be loaded by Novaloc attachment. While the other group will be loaded by Equator attachment. Implants will be functionally loaded after three months of insertion.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 69 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All patients' ridges should be covered with firm mucosa which is free from any signs of inflammation or ulceration.
  • •Patients should be free from any bone disorder and exhibit adequate height and width of the residual alveolar ridge.
  • •All patients must have sufficient inter arch space.

排除标准

  • •Patients with oral or systemic diseases.
  • •Patients with xerostomia or excessive salivation.
  • •Patients with parafunctional habits (bruxism or clenching).
  • •Heavy smoker or alcoholic patients.
  • •Patients with history of temporo-mandibular dysfunction.
  • •Patients with brain disorders or psychiatric disorders.

研究组 & 干预措施

control

Active Comparator

Equator attachment

干预措施: Novaloc attachment (Procedure)

study

Experimental

Novaloc attachment

干预措施: Equator attachment (Procedure)

结局指标

主要结局

Radiographic evaluation of bone height

时间窗: at baseline, 6 and 12 months

Radiographic evaluation of bone height around each implant and at distal extension area will be evaluated using cone beam CT (CBCT)

Radiographic evaluation of bone density

时间窗: at baseline, 6 and 12 months

Radiographic evaluation of bone density around implant and at distal extension area will be evaluated using cone beam CT (CBCT)

次要结局

  • Pocket depth(at baseline, 6 and 12 months)

研究者

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

Sara Hossam El-din Kadry Othman

Assistant lecturer

Al-Azhar University

研究点 (1)

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