Abstract
BackgroundThe volume of residual alveolar bone is critical to the survival of dental implants. When the volume of alveolar bone in the posterior maxillary region is less than 4 mm, maxillary sinus floor elevation (MSFE) with the lateral approach is an effective option. Traditionally, this standard approach is usually conducted at 4–6 months after tooth extraction (standard MSFE). However, defective dentition due to extraction can impair mastication during the period of bone remodeling, especially if the molars on both sides are severely compromised and must be extracted. MSFE before extraction (modified MSFE) can take full advantage of residual tooth strength. However, the effectiveness and practicability of the modified MSFE procedure remain unknown. Therefore, the aim of this study was to compare the clinical outcomes of modified vs. standard MSFE, in order to provide references to periodontists.Methods/designThe study cohort included 25 adult patients (50 surgery sites) recruited from Peking University Hospital and School of Stomatology who met the inclusion criteria. The two sides of each patient will be randomly divided into two groups: a test group-modified MSFE or a control group-standard MSFE. The surgical duration and patient-reported outcomes (visual analog scale for discomfort) will be documented. Clinical indicators, including implant survival rates, mucosal conditions, and complications, will be recorded every 6 months during the 5-year follow-up period. The volume of the alveolar bone and marginal bone level will be assessed radiographically (cone-beam CT and periapical films) every 6 months. Histological analysis of biopsy samples retrieved from both sides will be performed to evaluate the biological features of the bone.DiscussionThe current study will explore the implant survival rates, safety, reliability, effectiveness, and practicability of the modified MSFE procedure. Moreover, the extent of osteogenesis on the sinus floor will also be assessed. The results of this trial will provide strategies for the modified MSFE procedure to achieve ideal clinical outcomes.Trial registrationInternational Clinical Trials Registry Platform ChiCTR1900020648. Registered on 1 January 2019
Highlights
The volume of residual alveolar bone is critical to the survival of dental implants
For atrophied posterior maxilla with a residual bone height of less than 4 mm, it is wise to conduct maxillary sinus floor elevation (MSFE) surgery to optimize the condition of the bone prior to implantation [2]
In order to reduce the number of procedures, implantation is performed immediately after the MSFE procedure
Summary
As previously reported [16], MSFE before tooth extraction is both safe and reliable. the effectiveness of this procedure to reduce discomfort remains uncertain, especially when both sides of molars are periodontally compromised and must be extracted. At the same time, maintaining the tooth will minimize discomfort caused by defective oral function for a period of 3–4 months. We propose that this new clinical strategy will improve patient satisfaction with the procedure. The results of the present study will determine if the modified MSFE procedure, including indications, detailed methods, postoperational complications, and management, is beneficial. Fixing methods should be prepared beforehand as a back-up plan in case of perforation Trial status This trial has been registered at Chictr.org.cn and recruitment for the study is ongoing. Recruitment began on February 1, 2019, and is expected to be completed by February 1, 2021
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