Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

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Description Module


Ignite Creation Date: 2025-12-25 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 12:43 AM
NCT ID: NCT04481867
Brief Summary: This study aimed to evaluate the clinical complications that might be presented with osteotome and densah burs, as well as to assess the new bone generated at 6 months post-operatively using CBCT. The study hypothesis was that densah bur would show comparable results to osteotome-mediated sinus lifting
Detailed Description: Maxillary posterior edentulous area rehabilitation with implants is usually not an easy procedure and is considered a challenge to many prosthodontists. This is due to pneumatization of the maxillary sinus, poor bone density and volume, and difficult accessibility of this area. After tooth loss, the maxillary sinus tends to enlarge into the remaining residual ridge because of poor bone density and lack of functional stimulation by teeth.1 Rehabilitation with dental implants in the maxillary posterior area depends on the quantity and quality of bone available for implant placement. In order to place the implant in the best prosthetic position, regenerative surgical techniques are usually essential to correct the initial anatomical situation.2 Summer in 1994 introduced a less invasive technique than the lateral approach for sinus floor elevation, called the closed sinus lifting. Summer classified it in to osteotome sinus floor elevation and bone added osteotome sinus floor elevation. Osteotome depends on condensing the bone in implant bed site and pushing it laterally and upward, which raises the sinus floor. Although being successful and non-invasive, Summer's technique showed several surgical problems as heat generation-induced necrosis if not well irrigated, and delayed implant secondary stability, as well as some patient-related drawbacks as headache and vertigo.3 Fortunately, in 2014 Salah Huwais introduced new burs called densah burs that help preservation of bone health by condensing bone rather than removing it. Accordingly, this process was labeled osseodensification. In the past few years since the introduction of densah burs, limited number of studies evaluated its efficiency as well as patient perception to the procedure. 4 It is well established that cone beam computed tomography (CBCT) gives more profound and accurate assessment of pre- and post-operative implant sites. However, a meta-analysis was published in 2018 showed that most previous studies on lifting procedures used conventional 2D techniques, and very few applied CBCT as the diagnostic modality. This heterogeneity highly affected the quality of evidence retrieved. 5 This study aimed to validate the clinical complications that might be presented with osteotome and densah burs, as well as to assess the new bone generated at 6 months post-operatively using CBCT. The study hypothesis was that densah bur would show comparable results to osteotome-mediated sinus lifting.
Study: NCT04481867
Study Brief:
Protocol Section: NCT04481867