NCT02406924

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 2, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

March 30, 2015

Last Update Submit

April 1, 2015

Conditions

Alveolar Bone GraftingBone Augmentation

Keywords

pinparticulated graftbone augmentationvertical augmentationhorizontal augmentation

Outcome Measures

Primary Outcomes (4)

  • vertical gain

    Measures will be taken from computerized tomography in axial sections

    9 months

  • horizontal gain

    Measures will be taken from computerized tomography in transverse sections

    9 months

  • implants survival

    Clinical examination and standardized radiographs will be taken periodically

    24 months

  • soft tissue volume

    Measures will be taken from images generated by intraoral scanning in an occlusal view

    24 months

Study Arms (2)

Sausage graft

EXPERIMENTAL

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

Procedure: BiopsyRadiation: Computerized TomographyOther: Standardized periapical radiographsOther: Intraoral scanning

Bone block graft

ACTIVE COMPARATOR

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

Procedure: BiopsyRadiation: Computerized Tomography

Interventions

BiopsyPROCEDURE

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

Bone block graftSausage graft
Computerized TomographyRADIATION

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

Bone block graftSausage graft
Standardized periapical radiographsOTHER

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

Sausage graft
Intraoral scanningOTHER

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

Sausage graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • absence of teeth at anterior maxilla
  • need of vertical or horizontal bone reconstruction at anterior maxilla

You may not qualify if:

  • smoking habits
  • diabetes
  • systemic diseases which interfere with osseous metabolism
  • active periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Intraepithelial Neoplasia

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Carcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pedro Tortamano, PHD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline B Keedi, MSD

CONTACT

55 11 997981436carolbkeedi@gmail.com

Patricia S Gimenez, MSD

CONTACT

55 11 983832404patsgimenez@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

July 1, 2017

Last Updated

April 2, 2015

Record last verified: 2015-04