Missing Tooth/Teeth, Vertical Bone Defects
Conditions
Keywords
Sinus lifting, Dental implants, Bone grafting, Customized surgical guide
Brief summary
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.
Detailed description
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).
Interventions
PROCEDURETraditional sequence
Sinus elevation is performed, followed by implant placement, and finally packing the opened lateral window with bone graft, all using a customized surgical guide.
PROCEDUREModified sequence
Sinus elevation is performed, followed by packing the sinus with bone graft, and then implant osteotomies are drilled, all using a customized surgical guide.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age more than 18 years. * Both sexes. * Patients eligible for maxillary sinus elevation, implant, and bone graft procedures. * Adequate general health for dental interventions. * Vertical bone measurement of 5 mm or slightly more.
Exclusion criteria
* Systemic conditions affecting implant success. * Patients with vertical bone measurement less than 5 mm. * Previous sinus surgery or dental implant failure. * Medication that can impair or interfere with normal bone metabolism. * History of head and neck radiotherapy. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone density | 3 months and 6 months postoperative | Assessed using Cone-beam computed tomography (CBCT) and measured in Hounsfield Units (HU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vertical bone height gained | 3 months and 6 months postoperative | Evaluated using Cone-beam computed tomography (CBCT) and measured in millimeters (mm) |
| Bone volume | 3 months and 6 months postoperative | Computed using Cone-beam computed tomography (CBCT) and measured in cubic centimeters (cm3) |
| Implant stability | Immediately following implant placement and after 6 months postoperatively | Measured by an implant stability meter (OsstellISQ®) in ISQ VALUE |
Countries
Egypt
Contacts
CONTACTAhmed Atito Said Sayed, B. D. S
Outcome results
None listed