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

NCT ID: NCT02406924

Last Updated: 2015-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alveolar Bone Grafting Bone Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sausage graft

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

Group Type EXPERIMENTAL

Biopsy

Intervention Type PROCEDURE

A cylinder of grafted bone will be removed from the location elected for the implant installation with an appropriate trephine

Computerized Tomography

Intervention Type RADIATION

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

Standardized periapical radiographs

Intervention Type OTHER

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

Intervention Type OTHER

Intraoral scanning will be made before the graft, at implant installation, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation

Bone block graft

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

Group Type ACTIVE_COMPARATOR

Biopsy

Intervention Type PROCEDURE

A cylinder of grafted bone will be removed from the location elected for the implant installation with an appropriate trephine

Computerized Tomography

Intervention Type RADIATION

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

Interventions

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Biopsy

A cylinder of grafted bone will be removed from the location elected for the implant installation with an appropriate trephine

Intervention Type PROCEDURE

Computerized Tomography

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

Intervention Type RADIATION

Standardized periapical radiographs

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

Intervention Type OTHER

Intraoral scanning

Intraoral scanning will be made before the graft, at implant installation, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pedro Tortamano

OTHER

Sponsor Role lead

Responsible Party

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Pedro Tortamano

PHD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pedro Tortamano, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Central Contacts

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Caroline B Keedi, MSD

Role: CONTACT

55 11 997981436

Patricia S Gimenez, MSD

Role: CONTACT

55 11 983832404

Other Identifiers

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UniversidadeSP

Identifier Type: -

Identifier Source: org_study_id

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