An interventional study of Traditional sequence and Modified sequence in Vertical Bone Defects and Missing Tooth/Teeth, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
The aim of this randomized clinical trial is to evaluate the effect of changing the sequence of bone grafting during maxillary sinus lifting and simultaneous dental implant placement. The study compares a traditional sequence (sinus elevation, implant placement, then bone grafting) with a modified sequence (sinus elevation, bone grafting, then implant placement). Both procedures utilize a customized surgical guide and are performed on patients with a vertical bone measurement of 5 mm or slightly more. The primary goal is to assess bone density, along with secondary outcomes including vertical bone height gained, bone volume, and implant stability.
Maxillary sinus floor augmentation (MSFA) is a common procedure to restore vertical bone defects in the posterior maxilla to allow for oral rehabilitation using dental implants. However, traditional techniques can have demerits such as increased operative time, liability to infection, and increased complication rates. Despite advancements made to improve the surgical technique, several complications can yet arise which may compromise the success of the operation.
This study aims to enhance surgical sequences and compare the efficacy of sinus elevation, implant, and bone graft procedures using a customized surgical guide. The guide includes a lateral window for sinus elevation and a drill guiding hole for implant replacement. The study hypothesizes that the modified sequence (sinus elevation, bone graft, implant) is more accurate and provides better outcomes regarding bone density, stability, and height of the gained bone compared to the traditional sequence (sinus elevation, implant, bone graft).
Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Traditional sequence following standard protocols (sinus elevation, implant, bone graft) using a customized surgical guide.
Procedure: Traditional sequence
Modified sequence (sinus elevation, bone graft, and subsequent implant placement) using a customized surgical guide.
Procedure: Modified sequence
The surgical procedure involves the following standardized steps: Creation and elevation of a full-thickness mucoperiosteal flap. Seating of the customized surgical guide. Tracing the lateral window outline using a sterile surgical pencil. Removal of the surgical guide. Lateral window osteotomy and elevation of the Schneiderian membrane. Securing and protecting the elevated membrane using a blunt surgical instrument. Repositioning of the surgical guide. Preparation of the pilot osteotomy through the guide sleeve. Removal of the surgical guide and completion of the implant osteotomy sequence via a freehand approach. Implant insertion and cover screw placement. Packing of the particulate bone graft into the elevated subantral space. Placement of a resorbable biological membrane over the lateral window. Flap repositioning and suturing for primary closure.
The surgical procedure involves the following standardized steps: Creation and elevation of a full-thickness mucoperiosteal flap. Seating of the customized surgical guide. Tracing the lateral window outline using a sterile surgical pencil. Removal of the surgical guide. Lateral window osteotomy and elevation of the Schneiderian membrane. Securing and protecting the elevated membrane using a blunt surgical instrument. Repositioning of the surgical guide. Preparation of the pilot osteotomy through the guide sleeve. Removal of the surgical guide and completion of the implant osteotomy sequence via a freehand approach. Packing of the particulate bone graft into the elevated subantral space. Implant insertion and cover screw placement through the grafted site. Placement of a resorbable biological membrane over the lateral window. Flap repositioning and suturing for primary closure.
Bone density
Assessed using Cone-beam computed tomography (CBCT) and measured in Hounsfield Units (HU)
Time frame: 3 months and 6 months postoperative
Vertical bone height gained
Evaluated using Cone-beam computed tomography (CBCT) and measured in millimeters (mm)
Time frame: 3 months and 6 months postoperative
Bone volume
Computed using Cone-beam computed tomography (CBCT) and measured in cubic centimeters (cm3)
Time frame: 3 months and 6 months postoperative
Implant stability
Measured by an implant stability meter (OsstellISQ®) in ISQ VALUE
Time frame: Immediately following implant placement and after 6 months postoperatively
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Anodontia