跳至主要内容
临床试验/RBR-9hvrmz8
RBR-9hvrmz8尚未招募Unknown

Immediate placement delayed loading of a patient specific one piece cad/cam designed dental implant: a pivotal ide study

niversidade de São Paulo - Faculdade de Odontologia0 个研究点开始时间: 2023年9月15日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
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

  • Subjects 22 to 75 years of age. Both sexes. Subject indicated for single-rooted tooth or fused premolar roots atraumatic extraction with the intention for immediate implant placement that does not require bone augmentation (i.e., no lateral, vertical, or sinus augmentation required), the implant restoration will support a single-unit prosthetic restoration. Proposed implant sites should have intact cortical plates (at least 1 mm in thickness) and free of apical lesions or marginal bone loss. Implant sites with sufficient soft tissue quality, quantity, and morphology that do not require augmentation (thick phenotype). Subjects will have read, understood, and signed an institutional review board approved Informed Consent Form. Subjects must be able and willing to follow study procedures and instructions

排除标准

  • Subjects with a history of tobacco use within the last two years. Subjects with healing disorders (such as: diabetes mellitus confirmed HgA1C of > 7 within six months prior to screening, cancer, HIV, bone metabolic diseases or Type IV heart disease) that could compromise wound healing and/or preclude implant surgery; or who are currently receiving, or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and/or preclude oral surgery. Subjects taking any bisphosphonates; Subjects taking hormone therapy or have had a hysterectomy. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration. Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental). Subjects with proposed implant sites that demonstrate soft tissue recession or soft tissue deficiency that requires soft tissue augmentation. Subjects with untreated periodontal disease or other uncontrolled infections of the oral cavity. Subjects who have a bruxing or clenching habit. Subjects with insufficient oral hygiene (plaque score > 25%, bleeding on probing > 50% of sites). Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol. Subjects with cuspid protected occlusion, where full disclusion of all working side posterior teeth occurs in lateral movements. Subjects with other implant treatments currently in progress or who require replacement of additional teeth within the time frame of the study

研究者

发起方
niversidade de São Paulo - Faculdade de Odontologia

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