Currently accepted at: JMIR Research Protocols
Date Submitted: Apr 7, 2025
Date Accepted: Jul 9, 2025
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/75581
The final accepted version (not copyedited yet) is in this tab.
Crestal Sinus Lifting Using Osteotome, CAS Kit, and Osseodensification in Atrophic Posterior Maxilla (RBH 3–5 mm): Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Rehabilitation of the posterior maxilla with dental implants presents clinical challenges due to reduced residual bone height (RBH), sinus pneumatization, and compromised bone quality. Although lateral sinus floor elevation is traditionally recommended when RBH is less than 4–5 mm, it is often associated with higher morbidity. In contrast, transcrestal approaches have emerged as less invasive alternatives, especially with recent innovations such as osseodensification and the Crestal Approach to the Sinus (CAS) kit. These techniques aim to enhance implant stability while minimizing complications such as sinus membrane perforation. However, there remains a paucity of structured, evidence-driven protocols assessing their effectiveness in cases with severely resorbed bone and immediate implant placement.
Objective:
To design and implement a standardized clinical protocol that evaluates the comparative efficacy of three transcrestal sinus elevation techniques—osteotome, CAS kit, and osseodensification—for immediate implant placement in the atrophic posterior maxilla with RBH between 3 and 5 mm.
Methods:
This ongoing single-center, randomized controlled clinical trial is being conducted at the Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, Wardha. A total of 30 medically fit individuals requiring implant placement in the posterior maxilla, with RBH ranging from 3 to 5 mm, are being recruited. Participants are randomly assigned to one of three intervention arms: Group A (osteotome technique), Group B (CAS kit), and Group C (osseodensification). Each patient undergoes crestal sinus elevation followed by immediate implant placement. Key outcome variables include incidence of sinus membrane perforation, insertion torque values, implant stability (both primary and secondary), duration of procedure, and vertical bone gain at 6-month follow-up as evaluated on cone-beam computed tomography (CBCT). Data analysis will be performed using Fisher's exact test and appropriate statistical models, with a significance threshold of P < 0.05.
Results:
The study received ethical clearance from the Institutional Review Board in September 2023. Recruitment commenced in October 2023, and as of June 2025, 18 participants have been enrolled. Data acquisition and surgical interventions are ongoing, with final data collection expected to be completed by September 2025. Interim analyses are underway to assess preliminary trends in clinical performance and safety among the three groups.
Conclusions:
This protocol aims to bridge the existing gap in literature by offering a well-structured, evidence-based comparison of three minimally invasive sinus lift techniques for use in compromised maxillary sites. The outcomes are expected to inform clinical practice by identifying the most predictable and effective method for immediate implant placement in the posterior maxilla with limited RBH, thereby enhancing patient care and procedural success.
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.