Bone Augmentation Using Particulated Biomaterial and Autogenous Bone, Stabilized by Collagen Membrane and Pins (PaMP)

Pedro Tortamano

Status: Unknown

Conditions: Bone Augmentation; Alveolar Bone Grafting

Treatments: Radiation: Computerized Tomography; Other: Intraoral scanning; Other: Standardized periapical radiographs; Procedure: Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02406924

UniversidadeSP

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Sausage graft

Experimental group

Description:

Bone graft performed with a mixture of particulated autogenous and lyophilized bovine bone, stabilized with collagen membrane and pins.

Treatment:

Radiation: Computerized Tomography

Other: Standardized periapical radiographs

Procedure: Biopsy

Other: Intraoral scanning

Bone block graft

Active Comparator group

Description:

Bone graft performed with a block of autogenous bone stabilized by a screw associated with lyophilized bovine bone and collagen membrane.

Treatment:

Radiation: Computerized Tomography

Procedure: Biopsy