Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-01-01
Study Completion Date
2019-12-17
Brief Summary
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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
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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.
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.
Conditions
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Sinus Perforation
Keywords
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sinus augmentation
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Sinus elevation using "Low Window Sinus Lift" technique
Group Type
EXPERIMENTAL
Low Window Sinus Lift technique
Intervention Type
PROCEDURE
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
Interventions
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Low Window Sinus Lift technique
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
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Patients requiring implant placement in the posterior maxilla (Kennedy Classification: Class 1 and Class 2).
* Age between 20-60 years irrespective of the gender.
* Tooth extractions at the implant sites were performed at least 4 months before surgery.
* Residual bone height between the alveolar bone crest and the sinus floor ranges from 4 to 6 mm.
* Patients who are willing and fully capable to comply with the study protocol.
* Age between 20-60 years irrespective of the gender.
* Tooth extractions at the implant sites were performed at least 4 months before surgery.
* Residual bone height between the alveolar bone crest and the sinus floor ranges from 4 to 6 mm.
* Patients who are willing and fully capable to comply with the study protocol.
Exclusion Criteria
* Maxillary sinus pathologies (sinusitis, long standing nasal obstruction).
* Any disease contraindicating surgery (e.g. uncontrolled diabetes).
* Heavy smokers.
* Acute oral infections.
* Untreated periodontal disease.
* Poor oral hygiene.
* A history of radiotherapy or chemotherapy of the head and neck region.
* Pregnancy.
* Any disease contraindicating surgery (e.g. uncontrolled diabetes).
* Heavy smokers.
* Acute oral infections.
* Untreated periodontal disease.
* Poor oral hygiene.
* A history of radiotherapy or chemotherapy of the head and neck region.
* Pregnancy.
Minimum Eligible Age
20 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Hams Hamed Abdelrahman
OTHER
Sponsor Role
lead
Responsible Party
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Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Nagy H Elprince, pHd
Role: STUDY_DIRECTOR
Alexandria University
Riham M Fliefel, pHd
Role: STUDY_DIRECTOR
Alexandria University
Locations
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Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria, , Egypt
Site Status
Countries
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Egypt
References
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Aghaloo TL, Misch C, Lin GH, Iacono VJ, Wang HL. Bone Augmentation of the Edentulous Maxilla for Implant Placement: A Systematic Review. Int J Oral Maxillofac Implants. 2016;31 Suppl:s19-30. doi: 10.11607/jomi.16suppl.g1.
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Antonoglou GN, Stavropoulos A, Samara MD, Ioannidis A, Benic GI, Papageorgiou SN, Sandor GK. Clinical Performance of Dental Implants Following Sinus Floor Augmentation: A Systematic Review and Meta-Analysis of Clinical Trials with at Least 3 Years of Follow-up. Int J Oral Maxillofac Implants. 2018 May/Jun;33(3):e45-e65. doi: 10.11607/jomi.6417.
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Bornstein MM, Cionca N, Mombelli A. Systemic conditions and treatments as risks for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:12-27.
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Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. No abstract available.
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Cavalcanti MC, Guirado TE, Sapata VM, Costa C, Pannuti CM, Jung RE, Cesar Neto JB. Maxillary sinus floor pneumatization and alveolar ridge resorption after tooth loss: a cross-sectional study. Braz Oral Res. 2018 Aug 6;32:e64. doi: 10.1590/1807-3107BOR-2018.vol32.0064.
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Cosci F, Luccioli M. A new sinus lift technique in conjunction with placement of 265 implants: a 6-year retrospective study. Implant Dent. 2000;9(4):363-8. doi: 10.1097/00008505-200009040-00014.
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BACKGROUND
Danesh-Sani SA, Loomer PM, Wallace SS. A comprehensive clinical review of maxillary sinus floor elevation: anatomy, techniques, biomaterials and complications. Br J Oral Maxillofac Surg. 2016 Sep;54(7):724-30. doi: 10.1016/j.bjoms.2016.05.008. Epub 2016 May 25.
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Dula K, Mini R, van der Stelt PF, Buser D. The radiographic assessment of implant patients: decision-making criteria. Int J Oral Maxillofac Implants. 2001 Jan-Feb;16(1):80-9.
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Fugazzotto PA. The modified trephine/osteotome sinus augmentation technique: technical considerations and discussion of indications. Implant Dent. 2001;10(4):259-64. doi: 10.1097/00008505-200110000-00009.
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Hwang D, Wang HL. Medical contraindications to implant therapy: Part II: Relative contraindications. Implant Dent. 2007 Mar;16(1):13-23. doi: 10.1097/ID.0b013e31803276c8.
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Jivraj S, Chee W. Treatment planning of implants in posterior quadrants. Br Dent J. 2006 Jul 8;201(1):13-23. doi: 10.1038/sj.bdj.4813766.
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Johnson C. Measuring Pain. Visual Analog Scale Versus Numeric Pain Scale: What is the Difference? J Chiropr Med. 2005 Winter;4(1):43-4. doi: 10.1016/S0899-3467(07)60112-8.
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Liddelow G, Klineberg I. Patient-related risk factors for implant therapy. A critique of pertinent literature. Aust Dent J. 2011 Dec;56(4):417-26; quiz 441. doi: 10.1111/j.1834-7819.2011.01367.x.
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BACKGROUND
Lum AG, Ogata Y, Pagni SE, Hur Y. Association Between Sinus Membrane Thickness and Membrane Perforation in Lateral Window Sinus Augmentation: A Retrospective Study. J Periodontol. 2017 Jun;88(6):543-549. doi: 10.1902/jop.2017.160694. Epub 2017 Feb 26.
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BACKGROUND
Mandelaris GA, Rosenfeld AL. A novel approach to the antral sinus bone graft technique: the use of a prototype cutting guide for precise outlining of the lateral wall. A case report. Int J Periodontics Restorative Dent. 2008 Dec;28(6):569-75.
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Marin S, Kirnbauer B, Rugani P, Payer M, Jakse N. Potential risk factors for maxillary sinus membrane perforation and treatment outcome analysis. Clin Implant Dent Relat Res. 2019 Feb;21(1):66-72. doi: 10.1111/cid.12699. Epub 2018 Nov 26.
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Monje A, Monje F, Gonzalez-Garcia R, Suarez F, Galindo-Moreno P, Garcia-Nogales A, Wang HL. Influence of atrophic posterior maxilla ridge height on bone density and microarchitecture. Clin Implant Dent Relat Res. 2015 Feb;17(1):111-9. doi: 10.1111/cid.12075. Epub 2013 Apr 22.
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Osman AH, Mansour H, Atef M, Hakam M. Computer guided sinus floor elevation through lateral window approach with simultaneous implant placement. Clin Implant Dent Relat Res. 2018 Apr;20(2):137-143. doi: 10.1111/cid.12559. Epub 2017 Dec 1.
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Pal US, Sharma NK, Singh RK, Mahammad S, Mehrotra D, Singh N, Mandhyan D. Direct vs. indirect sinus lift procedure: A comparison. Natl J Maxillofac Surg. 2012 Jan;3(1):31-7. doi: 10.4103/0975-5950.102148.
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Sennerby L, Meredith N. Implant stability measurements using resonance frequency analysis: biological and biomechanical aspects and clinical implications. Periodontol 2000. 2008;47:51-66. doi: 10.1111/j.1600-0757.2008.00267.x. No abstract available.
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Shah SA, Khan I, Shah HS. Effectiveness of submucosal dexamethasone to control postoperative pain & swelling in apicectomy of maxillary anterior teeth. Int J Health Sci (Qassim). 2011 Jul;5(2):156-65.
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Simsek Kaya G, Daltaban O, Kaya M, Kocabalkan B, Sindel A, Akdag M. The potential clinical relevance of anatomical structures and variations of the maxillary sinus for planned sinus floor elevation procedures: A retrospective cone beam computed tomography study. Clin Implant Dent Relat Res. 2019 Feb;21(1):114-121. doi: 10.1111/cid.12703. Epub 2018 Dec 17.
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Stacchi C, Andolsek F, Berton F, Perinetti G, Navarra CO, Di Lenarda R. Intraoperative Complications During Sinus Floor Elevation with Lateral Approach: A Systematic Review. Int J Oral Maxillofac Implants. 2017 May/Jun;32(3):e107-e118. doi: 10.11607/jomi.4884.
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BACKGROUND
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Zaniol T, Zaniol A, Tedesco A, Ravazzolo S. The Low Window Sinus Lift: A CAD-CAM-Guided Surgical Technique for Lateral Sinus Augmentation: A Retrospective Case Series. Implant Dent. 2018 Aug;27(4):512-520. doi: 10.1097/ID.0000000000000776.
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Other Identifiers
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Sinus lift
Identifier Type: -
Identifier Source: org_study_id