An interventional study of Placement of extra short implants and maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation in Alveolar Bone Loss, sponsored by ARDEC Academy. Completed. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-22.
Sponsored by ARDEC Academy · Not applicable, Interventional, and Treatment
Recently, 4 mm long implants with a standard diameter have been used for the restoration of the posterior edentulous mandible with favorable results. However, randomized clinical trials reporting the results from full-arch fixed dental prosthesis that included 4 mm long implants placed in the posterior regions of the maxilla have not been published yet. The aim of the present study will be to compare the survival and success rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure
Two groups will be randomly prepared, the Short group and the Standard group. In the Short group, one 4 mm long and 4.1 mm in diameter implant (extra-short implant) will be installed in each side of the posterior region of the maxilla. In the Standard group, bilateral sinus floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in diameter implant (standard implant) will be installed into each augmented sinus. In the frontal region, four 10 mm long implants will be installed in both groups. Clinical assessments and x-rays will be taken at prosthesis delivering (6-8 weeks after implant installation), and after 6, 12, 18 and 24 months.
297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.
This study's enrollment of 20 is below the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →ARDEC Academy is the lead sponsor of 9 studies on the registry; none are open to participants now.
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the opposing arch have to present one of the following conditions:
Exclusion Criteria:
Local exclusion criteria
In each side of the posterior region of the maxilla, one tissue level implant, 4 mm long and 4.1 mm in diameter, will be installed
Procedure: Placement of extra short implants
sinus floor elevation with will be performed using natural bovine bone graft as filler material and porcine dermis collagen membrane to cover the antrostomy. After 4 months of healing, one bone level implant, 10 mm long and 4.1 mm in diameter, will be installed into each augmented sinus.
Procedure: maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation · Procedure: placement of standard implant
placement of an extra short implant in the posterior edentulous ridge
placement of standard implant in the posterior edentulous ridge after maxillary sinus augmentation
survival rate of 4 mm implants used as distal support
To compare the survival rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure.
Time frame: 24 months
Crestal bone level
Change of crestal bone level measured on intraoral x-ray applying a parallel technique from baseline (definitive prosthesis delivering) and 2-year follow-up. The distance between the implant margin and the first bone to implant contact will be measured in millimeters at the mesial and distal aspects of the Short and Standard implants.
Time frame: 24 months
Technical complications
Any technical complications related to implants, abutments, screw loosening, prosthetic fracture or chipping of the veneer material expressed in number of occurrence.
Time frame: 24 months
No study locations are listed for this record.
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Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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