Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria, Egypt
NCT Number: NCT04618588
The study group included 12 patients that were treated using the low window lateral sinus lift technique with simultaneous implant placement. This was facilitated using a CAD-CAM generated surgical guide. Subjective assessment on postoperative pain and swelling as well as objective assessment of implant stability, vertical bone height gained and complications such as Schneiderian membrane perforation rates and bleeding.
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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Alexandria, Egypt
Presurgical assessment of each patient was performed. Preoperative impressions were taken and study models were mounted. Orthopantogram (OPG) and cone beam computer tomography (CBCT) of the targeted areas were also done in order to evaluate residual bone height between the alveolar bone crest and the sinus floor, residual ridge width, bone quality and planning the number, size and position the implants.
Designing the surgical guide was performed using In2Guide™ system powered by OnDemand3D™.
The low window design was also planned where the lower osteotomy line will be flushed with the floor of the sinus, the upper line is 6mm of height from the lower line, the mesial line is flushed with the anterior wall and the distal line will correspond to the position of the most distal implant. The final product was fabricated using OnDemand3D™ which was then transferred to the 3d printer machine.
Patients were instructed to rinse with 0.125% chlorhexidine antiseptic mouth-wash for 2 minutes prior to surgery. The surgical area was anesthetized with local anesthesia. Infraorbital and greater palatine nerve blocks and local infiltration were given in order to properly anesthetize the area. A crestal incision was made in the posterior edentulous area followed by a vertical incision made at 45 degrees distal to the most anterior tooth. A full thickness mucoperiosteal flap was elevated at the surgical site enabling the apical osteotomy line to be drawn at a distance of 6mm above the residual bone height from the ridge. The customized surgical guide was secured in its proper position. After drilling, the anchor pin was placed in the prepared place. Using the standardized piezoelectric tip (SL1) with sterile saline irrigation, the outline of the window in the lateral maxillary sinus wall was formed.
The bone window was thinned down using the specialized DASK drill #4 and #5 from the DASK Kit until the grey shadow of the sinus membrane becomes visible. The sinus membrane at the circumference of the bony window was detached using the dome-shaped Sinus Membrane Elevator (XSE1L). Sinus membrane elevators (XSE2L), (XSE3L) and (XSE4L) were used to carefully lift the sinus membrane from the floor and anterior wall of the sinus to create adequate space for graft material (Figure 2-b). The membrane was further elevated to the medial wall in order to provide additional blood supply from that bone. The implants were drilled in the positions indicated by the surgical guide. Half the amount of the xenograft was introduced into the cavity followed by insertion of the dental implants. The dental implants were placed at torque 30~45N‧cm. Stability of the implants was measured using an implant stability meter.
Filling the cavity with the rest of the xenograft was completed after implant placement(s). The size of the collagen membrane was adjusted to match the size of the lateral bone window and then placed and stabilized by the cover screw. The flap was released by short horizontal cuts in the inner surface of the mucosa to provide a tension free flap. This was followed by closure of the flap with water tight sutures (horizontal mattress with a single interrupted it's centre) using 3/0 silk suture material.
After 6 months from the operation, a small incision was made directly over the implant and the cover screw was removed. Implant stability was measured again using the Osstell device. The abutment was placed at torque 25~30 N.cm. An impression was taken and sent to the lab for fixed prosthetics construction. The fixed prosthesis was cemented using glass ionomer cement.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Preoperative CBCT of surgical site and Fabrication CAD/CAM surgical stent, Sinus elevation using "Low Window Sinus Lift" technique, Implant, bone graft and membrane placement
Time frame: 6 months
Time frame: 1 week
This was assessed using a 10-point Visual Analogue Scale (VAS) in the 1st week postoperatively.
(0-1=None, 2-4=Mild-Moderate, 8-10= Severe)
Time frame: 6 months
Implant stability is measured using the Osstell device immediately following implant placement and 6 months postoperatively (prior to abutment loading).
Time frame: 1 week
This was assessed in the 1st week postoperatively and measured as follows:
Time frame: 6 months
Radiographic evaluation of bone density around each implant was done using OnDemand3D™ program.
Measurements were taken as follows:
Time frame: 6 months
4 reference points are selected on the CBCT. A vertical line immediately adjacent to the implant threads perpendicular to the horizontal line is drawn to a point on the bony floor of the maxillary sinus. From the cross-sectional view of 6 months postoperative, the distance from the crestal bone at the implant platform and the bone apical to the implant apex. The measurements are then subtracted from the preoperative bone height to obtain the amount of vertical bone height gained.
Time frame: 6 months
Marginal bone loss (MBL) were measured at the buccal and palatal aspects of each implant using the implant/abutment junction as a reference point to the most coronal bone-implant junction. Measurements were performed on the CBCT immediately after surgery (baseline) and 6 months postoperatively.
A decrease in this vertical distance between the reference point and the most coronal bone-implant contact on consecutive radiographs indicated a marginal bone loss (MBL).
Hams Hamed Abdelrahman
Other
Evaluation of Computer-guided Low Window Sinus Lift Technique (A Clinical Trial)
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