Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins
| Registry | NCT02406924, acronym PaMP |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 24 (Estimated) |
| Sponsor | Pedro Tortamano (Other) |
| Conditions | Alveolar Bone Grafting, Bone Augmentation |
| Interventions | Biopsy, Computerized Tomography, Standardized periapical radiographs, Intraoral scanning (Procedure, radiation, other) |
| Dates | start 2015-04-01, primary completion 2016-12-01 (estimated), completion 2017-07-01 (estimated), first posted 2015-04-02, last updated 2015-04-02 |
Related Papers Related Patents Related Grants Related Experts
All trials for Alveolar Bone Grafting All trials for Bone Augmentation All trials of Biopsy All trials of Computerized Tomography
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sausage graft | Experimental | Procedure: Biopsy; Radiation: Computerized Tomography; Other: Standardized periapical radiographs; Other: Intraoral scanning | Bone graft performed with a mixture of particulated autogenous and lyophilized bovine bone, stabilized with collagen membrane and pins. |
| Bone block graft | Active comparator | Procedure: Biopsy; Radiation: Computerized Tomography | Bone graft performed with a block of autogenous bone stabilized by a screw associated with lyophilized bovine bone and collagen membrane. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * absence of teeth at anterior maxilla * need of vertical or horizontal bone reconstruction at anterior maxilla Exclusion Criteria: * smoking habits * diabetes * systemic diseases which interfere with osseous metabolism * active periodontal disease