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临床试验/NCT06150755
NCT06150755尚未招募不适用

Evaluation of Marginal Bone Loss of Two Immediately Loaded Implants Retaining Mandibular Overdentures With Ball Attachment Versus Intra Oral Welding Titanium Bar a Randomized Clinical Trial

Ain Shams University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年12月24日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
54
试验地点
2
主要终点
marginal bone loss measurement

研究概览

简要总结

It is a randomized control clinical trial in which maxillary and mandibular dentures will be constructed, two implants will be inserted in the inter foraminal region in the edentulous mandible and immediate loading will be done. We will be comparing peri-implant marginal bone loss of two immediately loaded implants retaining mandibular overdentures with ball attachment versus intra oral welding titanium bar. Patient satisfaction will be assessed using oral health related quality of life.

详细描述

The patients will be divided in two groups, each group will receive maxillary and mandibular conventional heat cured acrylic resin complete dentures, which will be duplicated and provided by radio-opaque resin at the proposed implant sites to act as radiographic stents. Only patients with a D2 or D3 bone density will be included in the study. This will be confirmed by their cone beam computed tomographic (CBCT) scans of the mandible, while wearing radiographic stents.

The CBCT will be used to ensure sufficient bone width at the proposed implant sites, namely canine regions for implant diameter 3.7. Diagnostic set ups for all patients will be prepared to ensure a crown height space of at least 12 mm to accommodate the ball attachments for group I and intra oral welding bar for group II. Each group will receive two implants in the canine region through using surgical stent and immediate loading will be done.

Group B: immediate loading will be done using ball attachment and soft liners acting as female part for mandibular overdenture.

Group I: immediate loading will be done using intra oral welding titanium bar with 2 mm diameter and soft liner acting as a female part for mandibular overdenture.

For each group, marginal bone loss around the implants will be assessed at time of denture delivery and six months later. Patient satisfaction will be assessed using oral health related quality of life using (OHRQOL 14)

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

Blinding will be done by the outcomes assessor and one of the study authors will remove the prosthetic part before measuring crestal bone loss by outcome assessor through cone paralling technique. Blinding of the outcomes assessor for assessment by oral health questionnaire will be done as well

入排标准

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

入选标准

  • good oral hygiene
  • patient will be medically free
  • sufficient inter arch space

排除标准

  • heavy smoker
  • TMJ disorders
  • uncontrolled diabetes
  • flappy tissue

结局指标

主要结局

marginal bone loss measurement

时间窗: 6 months

marginal bone loss will be measured mesial and distal to the implant by radiographic cone paralling technique

次要结局

  • patient satisfaction(6 months)

研究者

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

Ahmed Mostafa Abdelfatah

associate professor of oral and maxillofacial prosthodontics

Ain Shams University

研究点 (2)

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