NCT04214054|Completed
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Sponsor study identifier
interventional
20
1 country
1
Study Start
May 13, 2018
Actual (reported)Primary Completion
April 20, 2019
Actual (reported)Study Completion
September 25, 2019
Actual (reported)This study was carried out to compare the outcome of sinus lift without grafting material, versus the use of moldable, self hardening calcium phosphate biomaterials with simultaneous implant placement.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 25, 2019
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 13, 2018
Actual (reported)April 20, 2019
Actual (reported)September 25, 2019
Actual (reported)December 26, 2019
Actual (reported)December 30, 2019
Actual (reported)Pain Evaluation
Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
1 week
Wound healing
The presence of alveolar osteitis (dry socket) will be determined clinically using BLUM'S criteria. Wound healing was assessed and recorded depending on the absence or presence of dehiscence, every opening along the incision will be recorded as dehiscence , dental tweezers will be used to identify it.
1 week
Radiographic Evaluation
Cone beam computed tomography (CBCT) was done. The apparatus and the settings were kept the same during all the preoperative scans to evaluate the amount of vertical bone height gained, the change of bone density and the marginal bone loss postoperatively.
6 months
Implant stability
Examining implant stability was done using Osstell (Osstell co. Swedan). It is a noninvasive and easy-to-use system to determine implant stability and to assess the process of osseointegration.
6 months
Easy graft, a moldable osteocondutive allograft formed of 60% hydroxylapatite and 40% β-tricalcium phosphate (Easy-graft, Sunstar, Gruidor, Degradable solutions AG, Swizerlard).
Incision was performed in the canine area then a full thickness mucoperiosteal flap was elevated and exposure of the lateral aspect of the maxillary sinus. Osteotomy of the buccal window was performed using the piezosurgery device followed by meticulous dissection of the sinus membrane. Drilling the site were implants were to be placed, guided by the preformed surgical stent. Implants of appropriate size were torqued to engage the apical aspect of the implant recipient site. The sinus was augmented with moldable self-hardening biphasic calcium phosphate. Repositioning and suturing of the flap using 3-0 black silk suture material.
Faculty of Dentistry, Alexandria University
Alexandria, 21512, Egypt
Mazor Z, Horowitz RA, Del Corso M, Prasad HS, Rohrer MD, Dohan Ehrenfest DM. Sinus floor augmentation with simultaneous implant placement using Choukroun's platelet-rich fibrin as the sole grafting material: a radiologic and histologic study at 6 months. J Periodontol. 2009 Dec;80(12):2056-64. doi: 10.1902/jop.2009.090252.
Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.
Shaimaa A. El Sadek, M.Sc
Faculty of Dentistry, Alexandria University, Egypt
Ahmed A. A. Sharara, PhD
Faculty of Dentistry, Alexandria University, Egypt
Magda M Saleh, PhD
Faculty of Dentistry, Alexandria University, Egypt
Nevien Shawky, PhD
Faculty of Dentistry, Alexandria University, Egypt
20 participants (actual enrollment reported by the registry).
First Submitted
December 26, 2019
First Posted
December 30, 2019
Study Start
May 13, 2018
Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation
A pyramidal full thickness mucoperiosteal flap was performed distal to the canine area with a crestal incision located palatally in the edentulous area and vertical extension of the incision to the buccal vestibule using Bard Parker blade number 15. The flap was reflected exposing the alveolar bone. Lateral window was performed and the sinus membrane was elevated using piezo surgery. Drilling at the sites where implants were to be placed was done using Neobiotech implant drilling Kit. Implants. Implants were placed in a self-tapping fashion using a torque wrench. Flaps were replaced back and sutured using 3-0 black silk suture material.
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Cha HS, Kim A, Nowzari H, Chang HS, Ahn KM. Simultaneous sinus lift and implant installation: prospective study of consecutive two hundred seventeen sinus lift and four hundred sixty-two implants. Clin Implant Dent Relat Res. 2014 Jun;16(3):337-47. doi: 10.1111/cid.12012. Epub 2012 Nov 15.
Primary Completion
April 20, 2019
Actual (reported)Study Completion
September 25, 2019
Actual (reported)Last Updated
August 20, 2020
Record last verified: 2020-08
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