Graftless Maxillary Sinus Augmentation With CGF Utilizing DIVA System

December 6, 2016 updated by: ruth angel dar, Western Galilee Hospital-Nahariya
This study is intended to evaluate the efficiency of graftless maxillary sinus augmentation with concentrated growth factor (CGF) utilizing "dynamic implant valve approach" (DIVA) system.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Crestal bone deficiency in the posterior maxilla may present a therapeutic challenge when dental implants are required. Sufficient bone volume is necessary for the long term survival of the implant .

The two most used surgical techniques are the crestal and the lateral window. The latter was first described by Tatum and subsequently, Boyene and James in 1980 . In the original technique, after fracturing the sinus floor, an implant was placed and submerged during the healing phase. The crestal osteotome technique is less invasive and was first described by Summers in 1994 . In this technique, a set of osteotomes is used to prepare the implant site, thereby allowing bone preservation.

Since the sinus augmentation was describes, bone grafts have been the mainstay of treatment. Variable bone grafts, such as autografts, allografts, xenografts, alloplasts, or combinations of different graft materials, have been used widely with similar results . Nonetheless, successful bone augmentation in the maxillary sinus, without bone grafting, have been reported in human and animal studies.

In 2011, Dong-Seok et al described sinus augmentation through a lateral window approach, using a fibrin rich block with concentrated growth factor (CGF). The researchers showed successful new bone formation in the sinus, with a success rate of 98% and no major complications .

Graftless Sinus augmentation relies on bioactive mediators that stimulate cell proliferation, matrix remodeling, and angiogenesis. CGF is one of the latest developments in this field, and is produced by processing blood samples with a special centrifuge device. It contains several mediators - platelet-derived growth factor (PDGF), transforming growth factor-b1 (TGF-b1) and b2 (TGF-b2), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). Because CGF is a dense fibrin matrix, richer in growth factors than other preparations, it has proved to have a better regenerative capacity and versatility .

As for the application of CGF, the introduction of the "dynamic implant valve approach" (DIVA), a minimally invasive approach procedure, enables the use of a closed bone augmentation technique. The implant was designed with an internal sealing screw that might serve as drug delivery system via its channel.

In this study, a graftless maxillary sinus augmentation with CGF will be performed utilizing DIVA system, and the bone formation will be periodically measured using panoramic X-ray and cone beam computerized tomography (CBCT).

In addition, in vitro cumulative release of selected growth factors of the CGF will be analyzed. The total quantity of growth factors will be checked using ELISA kits.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Nahariya, Israel
        • Western Galilee Medical Center

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No medical history of diseases involving bone metabolism
  • Patients that are treated by a prostodontist
  • Healthy oral cavity and sinuses, and good oral hygiene
  • No bone pathology demonstrated by X-ray
  • Residual sub-antral bone of at least 4mm as demonstrated by computerized tomography (CT)
  • The patient does not participate in another clinical study
  • The patient can read and understand the informed consent

Exclusion Criteria:

  • Medical history of a disease affecting bone metabolism (Diabetes Mellitus, heart disease, renal failure, osteoporosis)
  • Medical treatment that can affect bone metabolism (such as Bisphosphonates)
  • Patients treated with anticoagulants (such as Coumadin, Pradaxa)
  • Personal history of chemotherapy or radiotherapy
  • Patients with maxillary sinus pathology
  • Patients lacking a prostodontic treatment plan
  • Pregnant women

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment
maxillary sinus augmentation with CGF
Procedure: maxillary sinus augmentation with CGF
Graftless maxillary sinus augmentation surgery with CGF application utilizing DIVA system
Device: "dynamic implant valve approach" - DIVA system
The DIVA system will be used to apply the CGF to the maxillary sinus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone formation after sinus augmentation
Time Frame: one year

during postoperative follow-up, bone formation in the maxillary sinus will be assessed by periodic imaging.

after one year the investigators expect to see complete implant integration into the bone formed in the maxillary sinus(e.g; the dental implant is completely covered by bone).
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of growth factors released from the CGF matrix in vitro
Time Frame: one year
ELISA test will be used to quantify the released growth factors, and the data will be compared to the factors released from regular bone material.
one year

Collaborators and Investigators

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

Sponsor

Western Galilee Hospital-Nahariya

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

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

November 26, 2016

First Submitted That Met QC Criteria

December 3, 2016

First Posted (ESTIMATE)

December 7, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0153-16-NHR

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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