An interventional study of Biopsy and Computerized Tomography in Alveolar Bone Grafting and Bone Augmentation, sponsored by Pedro Tortamano. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-02.
Sponsored by Pedro Tortamano · Not applicable, Interventional, and Treatment
Twenty four patients with bone resorption on the anterior maxilla will be divided into two groups with different kinds of grafting: bone block associated with particulated biomaterial and particulated mixture of autogenous bone and biomaterial stabilized by collagen membrane and pins. The techniques will be compared according to volume gain, quality of graft osseointegration, implant survival and maintenance of the level of soft tissues.
Twenty four patients will be selected analysing the resorption on the front maxilla and will be divided into two groups. Experimental group will receive a particulated mixture of autogenous and lyophilized bovine bone, stabilized with a collagen membrane and pins over the vertical and/or horizontal defect, while Control group will receive a bone block graft, stabilized with fixation screws , covered with lyophilized bone and a collagen membrane. After a period of nine months, the volume increase will be measured trough the difference found between the initial computerized tomography and the final computerized tomography.
Dental implants will be placed according to the prosthetic need and bone cylinders will be removed from the respective location. The cylinders will be histologically analysed in order to verify the quality of the graft osteointegration. After the prosthesis installation, the implant survival and the soft and hard tissues will be followed up for a minimum period of 24 months.
This is the only study on the registry with Pedro Tortamano as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bone graft performed with a mixture of particulated autogenous and lyophilized bovine bone, stabilized with collagen membrane and pins.
Procedure: Biopsy · Radiation: Computerized Tomography · Other: Standardized periapical radiographs · Other: Intraoral scanning
Bone graft performed with a block of autogenous bone stabilized by a screw associated with lyophilized bovine bone and collagen membrane.
Procedure: Biopsy · Radiation: Computerized Tomography
A cylinder of grafted bone will be removed from the location elected for the implant installation with an appropriate trephine
An initial computerized tomography will be made before the first surgery, and a final computerized tomography will be made after 9 months, previously to the second surgery
A device will be adopted for the standardization, and radiographs will be taken at day 0, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation
Intraoral scanning will be made before the graft, at implant installation, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation
vertical gain
Measures will be taken from computerized tomography in axial sections
Time frame: 9 months
horizontal gain
Measures will be taken from computerized tomography in transverse sections
Time frame: 9 months
implants survival
Clinical examination and standardized radiographs will be taken periodically
Time frame: 24 months
soft tissue volume
Measures will be taken from images generated by intraoral scanning in an occlusal view
Time frame: 24 months
No study locations are listed for this record.
This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.