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临床试验/NCT03287934
NCT03287934已完成不适用

Accuracy of Selective Laser Sintered Computer Guided Stents Versus Digital Light Processing Stents in Immediate Implant Placement in Esthetic Zone, a Randomized Controlled Study

Cairo University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
evaluation of accuracy of implant placement clinical observation

研究概览

简要总结

patient with non-restorable tooth in the esthetic zone will be recruited in the study. a traumatic is done and implant will be placed using either digital light processed guides for control group or selective laser sintering group for intervention group.

详细描述

the principle investigator will randomize and equally distribute the Eligible patients between the selective laser sintering group (intervention group) and digital light processing group (control group).

  • Diagnostic phase : for initial diagnosis, principle investigator will make primary impression , bite registration, face bow record and periapical x-ray for each eligible patients. The tooth to be extracted will be removed from the cast and replaced with an artificial tooth. For construction of radio graphic stent, a clear thermoplastic sheet will be pressed on the modified cast using a vacuum forming machine . A hole is done in the center of the artificial tooth packed with heated gutta percha (radiopaque material) for easy visualization on the cone beam during virtual implant placing. A dual scan protocol with cone beam CT will be made. The first scan is for the patient wearing the scan appliance while the second will be for the cast with the scan appliance.
  • Planning phase : placing of the virtual implant and designing of the surgical stent will be done by virtual planning software .
  • Construction of the surgical guide: principle investigator will send the Standard Language transformation (STL) file of the designed guide to a rapid prototyping center. Selective laser sintering and digital light procesing will be used for intervention and control group respectively. principle investigator will check for adaption of the guide on the cast and cement the metallic sleeve to prevent rotation during surgery.
  • Surgical phase : principle investigator will prescribe a prophylactic antibiotic to the patient three days prior the surgery. Atraumatic extraction will be carried by periotomes and lancet. The integrity of the socket will be examined well by probe. The guide is stabilized in its place then drilling and implant placement will be done. Healing abutment is screwed in place to allow proper healing of the soft tissue. Patient will be instructed to avoid hard foods and follow restrict oral hygiene measures. Patient will be recalled after one week for postoperative inspection and assessment. A cone beam CT will be taken for deviation assessment.

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)

盲法说明

due to the nature of study only the participants could be blinded

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age should be more than 18 years old
  • Hopeless tooth in esthetic zone due to caries, endodontical problem or trauma with both neighboring teeth present.
  • Good oral hygiene
  • No periapical lesions (acute accesses or chronic fistula)
  • Adequate bone (5 mm) below the tooth to allow primary implant stability
  • Sufficient Medio-distal bone about 1.5 from each side
  • sufficient labial bone
  • sufficient band of keratinized mucosa

排除标准

  • heavy smoking
  • any systemic condition that is considered absolute contraindication for implant placement
  • in adequate inter-arch space
  • parafunctional habits as bruxism

结局指标

主要结局

evaluation of accuracy of implant placement clinical observation

时间窗: 1 week

measuring both angular and linear deviation of implants by virtual ruler in terms of mm

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

mahetab hamdi

principal investigator

Cairo University

研究点 (2)

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