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SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW

This study will compare patient-reported outcomes, as well as the type and incidence of complications, and bone marginal loss after 12 months in implants installed using the transcrestal approach (tSFE) with an osseodensification system (performed according to the protocol by Huwais et al. 2018), or installed simultane

Condition(s)Sinus Tract, Dental Implant Failed
StatusRecruiting
PhaseNA
Study typeInterventional
SummaryThis study will compare patient-reported outcomes, as well as the type and incidence of complications, and bone marginal loss after 12 months in implants installed using the transcrestal approach (tSFE) with an osseodensification system (performed according to the protocol by Huwais et al. 2018), or installed simultaneously using the lateral window technique (lSFE) with sinus lift. A blind, randomized, controlled clinical trial will be carried out with individuals over 18 years old, and with single tooth loss in the posterior maxilla, where the residual bone height (RBH) is 3 to 5 mm. The tSFE will be performed with osseodensification burs (Densa Bur, Versah, USA) using a counterclockwise motion, associated to synthetic biomaterial (hydroxyapatite and beta-tricalcium phosphate). The lSFE t
Who can participateInclusion Criteria: * Maxillary sinuses that have residual bone height between at least 3 mm and 5 mm; * Width of the residual bone ridge that allows the insertion of an implant with a diameter of 4 mm; * Tomographic thickness of Schneider's membrane with a maximum of 5 mm in the region to be operated; * Residual ridge with ≥2 mm of medullary bone in the bucco-palatal direction, with a 1/1 ratio of medullary and cortical bone to achieve predictable plastic expansion; * Patients with adequate interarch space for placement of the prosthetic crown; * Good physical health status (ASA1 and ASA2, according to the Physical Status Classification System - American Society of Anesthesiologists); * At least 6 months since the last tooth loss in the region to be operated; Exclusion Criteria: * \- Thos
Ages18 Years
SexAll
Accepts healthy volunteersYes
Lead sponsorFederal University of Rio Grande do Sul
LocationsPorto Alegre, Rio Grande do Sul, Brazil
Start date2022-10-01
NCT IDNCT06123221
Official listinghttps://clinicaltrials.gov/study/NCT06123221

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