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临床试验/NCT03211819
NCT03211819已完成不适用

Esthetic Outcome of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.

Cairo University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月15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
20
试验地点
2
主要终点
Pink Esthetic Score (PES)

研究概览

简要总结

Patients with fractured anterior teeth indicated for extraction will be recruited to the study. After Extraction of the tooth the socket will be evaluated and if eligible for immediate implant placement, implants will be placed either by free hand or computer guided technique. The pink esthetic score will be evaluated to be the primary outcome.

详细描述

After diagnosis and history taking the patient will be informed about the sequences of the trial. If the patient wishes to participate and fulfills the clinical examination inclusion criteria, he/she will be sent to perform a Cone Beam Computer Tomography (CBCT) scan while biting on a cotton roll and placing cotton rolls in the vestibule to separate the teeth of interest from the opposing dentition and lips respectively.

Then the investigator will examine the CBCT to ensure the presence of sufficient labial bone. Only patients with sufficient labial bone (1.5-2 mm) will be included in the study. If the patient has less than 1.5 mm labial bone, he/she won't be eligible for immediate implant placement and would be referred to delayed implant placement.

The eligible patients will be recalled for impression making. The principal investigator will do a vacuum stent (2mm hard) on the obtained study cast for temporary crown fabrication after the surgery. The tooth or root to be extracted will be modified on the cast and an artificial tooth would be placed then the vacuum sheet will be pressed on the cast.

At this appointment (impression making) the patient will choose a sealed envelope containing the allocation either to the computer guided group (test group) or free hand group (control group). The patient's name will be written on the envelope to avoid changing the randomization process.

For the test group, the principal investigator (AK) will do virtual planning using Blue Sky ® implant planning software. Proper implant size and diameter will be used and a virtual surgical guide will be constructed in a Standard Triangulation Language (STL) format and exported to a 3D printing machine for printing. After printing the guide would be rechecked for adaptation on the study cast. A metallic sleeve will be placed and adapted to the surgical guide in the proposed implant site, using adhesive to avoid rotation during surgery.

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

due to the nature of the trial only the outcome assessror will be masked from the intervention or control group

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with teeth or remaining roots indicated for extraction in the esthetic zone and eligible for immediate implant placement
  • Sufficient bone labially (at least 1.5-2 mm) assessed after cone beam computer tomography (CBCT) scan
  • Presence of adequate mesio-distal length between the adjacent natural teeth (at least 7 mm), measured on the study cast
  • No overeruption of the opposing teeth to avoid any premature contact with the temporary crown during the osseointegration period.

排除标准

  • Presence of active sings or symptoms of acute infection in the tooth or the remaining root
  • Heavy smokers (more than 2 packs per day)
  • Parafunctional habits (clenching or bruxism) diagnosed by history taking and observation of the occlusal surface of the posterior teeth for wear facets
  • Patients with poor oral hygiene
  • Pregnant women
  • Any systemic condition that may interfere with osseointegration (as uncontrolled diabetes, recent head and neck radiation)

结局指标

主要结局

Pink Esthetic Score (PES)

时间窗: 1 week postoperative to definitive crown

a scoring system of five points are to be checked and evaluated where 0=incomplete; 1= partially present; 2= completely present

次要结局

  • Gingival recession(1 week and 6 month postoperatively)

研究者

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

Ahmed Kotb

Assisstant Lecturer- Prosthodontic Department- Faculty of Dentistry- Principle Investigator

Cairo University

研究点 (2)

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