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临床试验/RBR-848ygb3
RBR-848ygb3进行中(未招募)Unknown

Immediate placement delayed loading of a patient-specific one-piece CAD/CAM designed dental implant: a pilot study

Faculdade de Odontologia da Universidade de São Paulo0 个研究点开始时间: 2023年10月20日最近更新:
适应症

试验速览

阶段
Unknown
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
22Y 至 75Y(—)

入选标准

  • Age between 22 to 75 years; Indication for the extraction of a single-rooted tooth with immediate implant placement for a single-unit prosthetic restoration; Adequate bone height and width with intact cortical plates (> 1 mm in thickness) at the surgical site for implant placement; Satisfactory soft tissue quality, quantity, and morphology; Ability to fully comprehend and provide informed consent; willingness and ability to adhere to study procedures and instruction

排除标准

  • General contraindications for dental and/or surgical treatments; Presence of apical lesions or peri-radicular bone loss; Untreated periodontitis, peri-implantitis, or other uncontrolled oral infections; Inadequate oral hygiene (plaque score > 25% or bleeding on probing > 50% of sites); Bruxing or clenching habits; Cuspid protected occlusion; Presence of diabetes, cancer, HIV infection, or bone metabolic diseases; Concurrent or recent use of immunosuppressants, systemic corticosteroids, intramuscular or intravenous bisphosphonates within two months prior to the study; Undergoing or having undergone radiation therapy and/or chemotherapy; Current smokers or individuals who had not quit smoking for at least two years; Pregnant or lactating women, and women of childbearing age intending to become pregnant during the study; Individuals requiring replacement of additional teeth during the study period or with ongoing implant treatments; or participants in other studies clinical studies involving therapeutic intervention (medical or dental);
  • Additional exclusion criteria specific to the time of tooth extraction and implant insertion:
  • Exclusion criteria at time of extraction:
  • Insufficient or fractured bone at the extraction site (buccal plate < 1 mm thick or fenestrations); Fractured, chipped, or distorted tooth root pos-extraction; Significant defect in the extraction socket with one or more missing bone walls; Active infection present in the extraction socket; Communication between the extraction socket and sinus, inferior alveolar nerve canal or mental foramina; Tooth root not compatible with the dimensions of the intended implant device;
  • Exclusion criteria at time of implant insertion:
  • Presence of infection, pain, bleeding, or significant tissue swelling or trauma before implant placement; Change in medical or dental history that related to the exclusion criteria before tooth extraction; Failure to place the implant within 14 days of the extraction

研究者

发起方
Faculdade de Odontologia da Universidade de São Paulo

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