Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04618588
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2020-11-01
Brief Title:
Computer Guided Low Window Sinus Lift Technique
Sponsor:
Hams Hamed Abdelrahman
Organization:
Alexandria University
Study Overview
Official Title:
Evaluation of Computer-guided Low Window Sinus Lift Technique A Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 0125 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 3045Ncm Stability of the implants was measured using an implant stability meter
Filling the cavity with the rest of the xenograft was completed after implant placements 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 its centre using 30 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 2530 Ncm An impression was taken and sent to the lab for fixed prosthetics construction The fixed prosthesis was cemented using glass ionomer cement
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 0125 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 3045Ncm Stability of the implants was measured using an implant stability meter
Filling the cavity with the rest of the xenograft was completed after implant placements 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 its centre using 30 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 2530 Ncm An impression was taken and sent to the lab for fixed prosthetics construction The fixed prosthesis was cemented using glass ionomer cement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None