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临床试验/NCT05709236
NCT05709236已完成不适用

Clinical Assessment of Maxillary Screw-retained Implant Prosthesis Fabricated From Digital Versus Conventional Full-arch Implant Impression: A Randomized Controlled Clinical Trial

Delta University for Science and Technology1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年1月5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
28
试验地点
1
主要终点
Number of events of prosthodontic complications

研究概览

简要总结

28 participants with edentulous maxillary arches were randomly selected and enrolled in two equal groups; Group I conventional impression group (CIG) and Group II Digital impression group (DIG). All patients were rehabilitated with maxillary screw-retained implant prosthesis retained by 6 implants. Prosthodontic complications and peri-implant MBL were registered at 6,12, and 24 months (m). Data was collected and statistically analyzed.

详细描述

Treatment sequence Pretreatment examination For all participants, diagnosis and treatment planning were performed. They were assessed clinically through oral examination by inspection and palpation, and radiographically using preoperative panoramic radiograph and cone beam computed tomography CBCT to evaluate bone morphology, bone height, bone density, and vertical as well as horizontal bone resorption.

New maxillary complete dentures were fabricated for all participants to serve as temporization and to perform prosthetically driven computer guided implant placement. Preoperative CBCT scan (i-CAT Visions; Imaging Sciences International, Hatfield, PA, USA) was performed for all participants using the newly fabricated dentures with extra oral ready-made radiopaque markers. The markers were placed in relation to the maxillary dentures laterals/canines position, first premolars position, and first molars position. The superimposition of these markers on the maxilla determines the potential implants sites. Implant planning was performed and a stereolithographic surgical guide was fabricated with 6 sleeves on these preplanned implants sites.

Surgical procedures Computer-guided surgery was performed; each participant of both groups received six axially placed implants (Neobiotech, South korea) in the preplanned implant positions in maxilla. The final insertion torque for implants was 40 N cm. Post-operative instructions were given for patients. Chlorhexidine mouth wash 0.2% was prescribed for two weeks.

Prosthetic procedures Patients of both groups were recalled after a healing period of soft and hard tissues of four months for second stage surgery. Transmucosal titanium abutments were screwed in after uncovering of the six implants. For the fabrication of the definitive prosthesis, two different approaches were implemented: conventional pick up versus digital impressions.

For group I patients (CIG), a conventional open tray full- arch implant impression was implemented to fabricate the definitive maxillary screw retained prosthesis. Six long impression transfers were screwed over the fixtures. Using a periapical radiographs the seating of the open-tray long impression copings was confirmed. Splinting of impression copings was performed using special resin (Duralay; Reliance Dental, Alsip, IL, USA) (Fig----). Conventional border molding of the custom open trays (Fig----) was performed, then light body vinyl polysiloxane (Imprint 3, 3M ESPE, St. Paul, MN, USA) was injected around the impression transfer (Fig---). The tray was then filled with a heavy body vinyl polysiloxane ((Imprint 3, 3M ESPE, St. Paul, MN, USA) and a conventional pick up impression was made. Implant analogues were then attached to the impression copings and stone models were pored to replicate the exact implant positions in the cast.

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)

入排标准

年龄范围
56 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with maxillary edentulous ridges opposing fully dentulous mandibular arch or with a minimum of six anterior teeth (canine to canine), and the utmost one or two premolar/molar missing in any quadrant
  • patients with compromised facial/lip support seeking a fixed prosthesis for their edentulous maxilla
  • having edentulous maxilla with adequate bone density and height to place six implants as assessed clinically and radiographically, and physically
  • psychologically eligible patients for implants placement.

排除标准

  • debarred medically compromised patients
  • patients suffering from parafunctional habits.

结局指标

主要结局

Number of events of prosthodontic complications

时间窗: - 6 months, 12 months and 24 months

For both groups, the prosthodontic complications of the maxillary screw-retained implant prosthesis were monitored and calculated during the twenty four months follow up period according to the following events: Loss of the cover of access hole, Framework fracture, Fractured acrylic resin, Prosthetic teeth fracture, Screw loosening of the abutment, Screw fracture of the abutment, Screw loosening of the prosthesis, Screw fracture of the prosthesis.

次要结局

  • Amount of marginal bone loss(6 months, 12 months and 24 months)

研究者

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

Wafaa Ibrahim

Associate Professor

Delta University for Science and Technology

研究点 (1)

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