Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting

May 10, 2016 updated by: Maria Cristina Zindel Deboni, University of Sao Paulo

Histological and Microtomographic Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting: A Randomized Clinical Trial

Bone resorption and atrophy in maxillary posterior region is due to severe periodontal disease and is consequent tooth extractions. Sinus pneumatisation can occur after tooth extraction and alveolar bone loss. Consequently, bone-reducing volume at that region is a great challenge to implantodontists. Sinus lifting surgery have been practiced since 80's and many biomaterials have been used to solve filling issues to maintain the sinus floor lifted in a position that can allow dental implants installation. Bone grafts have shown to be the best choice of filling grafts. Despite autologous bone are the gold standard filling biomaterial it is associates with great mortality and morbidity. So, bone allografts from tissue bank had been shown to be an advantageous alternative. Lyophilized or freeze tissue bone are the most common allografts but literature is poor in randomized controlled parallel clinical trials regarding those filling grafts for sinus lifting. The aim of this study is to perform a randomized controlled clinical trial comparing two bone allografts: lyophilized and freeze bone allografts from human bone tissue bank. The investigators want to verify which one can develop greater osteogenesis, if is there any difference between them regarding the architectural trabeculae formation, if there are different patterns of reabsorption and finally if is there any differences between them regarding primary and lately dental implants stability. To answer those questions the investigators propose firstly, to carry out microtomographic and histological analysis from trephine bone samples after six months of sinus lifting and grafting in healthy participants undergoing osseointegrated dental implants. Secondly, the primary and lately implant stability is going to be achieved employing Resonance Frequency Analysis (RFA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

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

28 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy
  • totally or partially edentulous patients, bilaterally, in upper premolar or molar region; presenting maxillary sinus lifting necessity with bilateral alveolar bone height lower than 5mm and indication for at least one osseointegrated dental implant in premolar or molar region.

Exclusion Criteria:

  • recent sinusitis history
  • hypersensibility for sinus allergens, tabagism, ethylism
  • severe periodontal disease, diabetes, hypertension.
  • Cases that occur schneiderian membrane perforation will be excluded from the final sample.

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: group lyophilized bone allograft
sinus lifting with tissue bank lyophilized bone filling
Procedure: lyophilized bone allograft
sinus lifting filling procedure employing lyophilized bone allograft from tissue bone bank.
Active Comparator: group freeze bone allograft
sinus lifting with freeze bone bank filling
Procedure: freeze bone allograft
sinus lifting filling procedure employing freeze bone allograft from tissue bone bank.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume of bone neoformation in mm3
Time Frame: six months after grafting
computational software for analysis the micro CT scanning of trephine bone samples images
six months after grafting
area of bone neoformation in μm2
Time Frame: six months after grafting
IMAGEJ histomorphometric software for analysis of trephine bone samples micrographic images
six months after grafting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dental implants stability value
Time Frame: six months after grafting
primary implant stability by Resonance Frequency Analysis (RFA) in ISQ
six months after grafting
dental implants stability value
Time Frame: six months after dental implant
late stability by Resonance Frequency analysis (RFA) in ISQ
six months after dental implant

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

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

June 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

October 21, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAEE 30738714.0.0000.0075.

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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