Factors Influencing Bone Block Allograft Resorption

January 19, 2018 updated by: Jesús Torres García Denche, Universidad Complutense de Madrid

Factors Influencing Bone Block Allograft Resorption. A Randomized Clinical Trial

A main drawback of bone block graft surgery is the resorption occurring in early stages of healing. The aim of this work was investigate different factors associated with graft resorption in allogeneic bone block graft surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: A main drawback of bone block graft surgery is the resorption occurring in early stages of healing. The aim of this work was investigate different factors associated with graft resorption in allogeneic bone block graft surgery.

Materials and methods: Twenty-eight patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (<4 mm) were included in the study. Patients received freeze dried bone allograft (FDBA) blocks of either allogeneic cancellous or cortico-cancellous bone obtained from the iliac crest. The aforementioned groups were compared in regards to bone resorption using General Estimating Equations (GEE) and logistic regression. Demographic data, trabecular bone density, graft site were also analyzed.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Twenty eight totally and partially edentulous patients referred for dental implant therapy from January 2011 to September 2015 were enrolled in the study. All patients had insufficient bucco-lingual (BL) alveolar bone width (<4 mm) that prevented placement of regular size implants

Exclusion Criteria:

  • Patients with severe systemic disease (American Society of Anesthesiology III or IV) were excluded from the study. In addition, patients who were pregnant, or patients with diseases affecting bone, such as Paget's disease, osteomalacia, diabetes, vitamin D deficiency, alcoholism, hyperthyroidism cancer or osteoporosis as well as those on medications that might affect bone metabolism, such as bisphosphonates, corticosteroids or antiepileptic medicaments were also excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cortico-Cancellous
Graft surgery with cortico-cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement
Procedure: graft surgery
A graft surgery using bone allogenic blocks that are screwed over the atrophic sites of the maxilla to obtain bone augmentation to support dental implants
Active Comparator: Cancellous
Graft surgery with cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement
Procedure: graft surgery
A graft surgery using bone allogenic blocks that are screwed over the atrophic sites of the maxilla to obtain bone augmentation to support dental implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Bone Augmentation
Time Frame: 0 months
A region of interest (ROI) containing the entire trabecular bone area of the alveolar ridge was created using the closed polygon tool of the OsiriX software.
0 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of bone resorption
Time Frame: 4 months
A region of interest (ROI) containing the entire trabecular bone area of the alveolar ridge was created using the closed polygon tool of the OsiriX software.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Investigators

  • Principal Investigator: Jesus Torres, Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

January 14, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P-15/566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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