Faculty of Dentistry, Cairo University
Cairo, Egypt
Location status: Recruiting
Location contact
Hesham El-Hawary, Phd
PRINCIPAL_INVESTIGATOR
Hesham El-Hawary, Professor
CONTACT
NCT Number: NCT07816107
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Cairo, Egypt
Location status: Recruiting
Hesham El-Hawary, Phd
PRINCIPAL_INVESTIGATOR
Hesham El-Hawary, Professor
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sinus elevation is performed, followed by implant placement, and finally packing the opened lateral window with bone graft, all using a customized surgical guide.
Sinus elevation is performed, followed by packing the sinus with bone graft, and then implant osteotomies are drilled, all using a customized surgical guide.
Time frame: 3 months and 6 months postoperative
Assessed using Cone-beam computed tomography (CBCT) and measured in Hounsfield Units (HU)
Time frame: 3 months and 6 months postoperative
Evaluated using Cone-beam computed tomography (CBCT) and measured in millimeters (mm)
Time frame: 3 months and 6 months postoperative
Computed using Cone-beam computed tomography (CBCT) and measured in cubic centimeters (cm3)
Time frame: Immediately following implant placement and after 6 months postoperatively
Measured by an implant stability meter (OsstellISQ®) in ISQ VALUE
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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