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Graftless Maxillary Sinus Augmentation With CGF Utilizing DIVA System

Primary Purpose

Alveolar Bone Loss

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
maxillary sinus augmentation with CGF
"dynamic implant valve approach" - DIVA system
Sponsored by
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring CGF, sinus augmentation, DIVA, Platelet-Rich Plasma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Western Galilee Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

maxillary sinus augmentation with CGF

Outcomes

Primary Outcome Measures

bone formation after sinus augmentation
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).

Secondary Outcome Measures

Quantification of growth factors released from the CGF matrix in vitro
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.

Full Information

First Posted
November 26, 2016
Last Updated
December 6, 2016
Sponsor
Western Galilee Hospital-Nahariya
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1. Study Identification

Unique Protocol Identification Number
NCT02985645
Brief Title
Graftless Maxillary Sinus Augmentation With CGF Utilizing DIVA System
Official Title
Graftless Maxillary Sinus Augmentation With CGF Utilizing DIVA System
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Galilee Hospital-Nahariya

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
CGF, sinus augmentation, DIVA, Platelet-Rich Plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
maxillary sinus augmentation with CGF
Intervention Type
Procedure
Intervention Name(s)
maxillary sinus augmentation with CGF
Intervention Description
Graftless maxillary sinus augmentation surgery with CGF application utilizing DIVA system
Intervention Type
Device
Intervention Name(s)
"dynamic implant valve approach" - DIVA system
Intervention Description
The DIVA system will be used to apply the CGF to the maxillary sinus.
Primary Outcome Measure Information:
Title
bone formation after sinus augmentation
Description
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).
Time Frame
one year
Secondary Outcome Measure Information:
Title
Quantification of growth factors released from the CGF matrix in vitro
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Angel-Dar, Dr.
Phone
+972-4-9107076
Email
rutiangel123@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Samer Srouji, Prof.
Phone
+972-4-9107270
Email
dr.samersrouji@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samer Srouji, Prof.
Organizational Affiliation
Western Galilee Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Western Galilee Medical Center
City
Nahariya
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigal Shor
Phone
+972-4-9107270
Email
sigal.shor@naharia.health.gov.il

12. IPD Sharing Statement

Citations:
PubMed Identifier
22082056
Citation
Del Fabbro M, Corbella S, Weinstein T, Ceresoli V, Taschieri S. Implant survival rates after osteotome-mediated maxillary sinus augmentation: a systematic review. Clin Implant Dent Relat Res. 2012 May;14 Suppl 1:e159-68. doi: 10.1111/j.1708-8208.2011.00399.x. Epub 2011 Nov 14.
Results Reference
background
PubMed Identifier
3516738
Citation
Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
Results Reference
background
PubMed Identifier
7994726
Citation
Summers RB. The osteotome technique: Part 3--Less invasive methods of elevating the sinus floor. Compendium. 1994 Jun;15(6):698, 700, 702-4 passim; quiz 710.
Results Reference
background
PubMed Identifier
27235382
Citation
Danesh-Sani SA, Loomer PM, Wallace SS. A comprehensive clinical review of maxillary sinus floor elevation: anatomy, techniques, biomaterials and complications. Br J Oral Maxillofac Surg. 2016 Sep;54(7):724-30. doi: 10.1016/j.bjoms.2016.05.008. Epub 2016 May 25.
Results Reference
background
PubMed Identifier
27256011
Citation
Falah M, Sohn DS, Srouji S. Graftless sinus augmentation with simultaneous dental implant placement: clinical results and biological perspectives. Int J Oral Maxillofac Surg. 2016 Sep;45(9):1147-53. doi: 10.1016/j.ijom.2016.05.006. Epub 2016 May 31.
Results Reference
background
PubMed Identifier
20523182
Citation
Sohn DS, Kim WS, An KM, Song KJ, Lee JM, Mun YS. Comparative histomorphometric analysis of maxillary sinus augmentation with and without bone grafting in rabbit. Implant Dent. 2010 Jun;19(3):259-70. doi: 10.1097/ID.0b013e3181df1406.
Results Reference
background
PubMed Identifier
21881519
Citation
Sohn DS, Heo JU, Kwak DH, Kim DE, Kim JM, Moon JW, Lee JH, Park IS. Bone regeneration in the maxillary sinus using an autologous fibrin-rich block with concentrated growth factors alone. Implant Dent. 2011 Oct;20(5):389-95. doi: 10.1097/ID.0b013e31822f7a70.
Results Reference
background
PubMed Identifier
21780251
Citation
Rodella LF, Favero G, Boninsegna R, Buffoli B, Labanca M, Scari G, Sacco L, Batani T, Rezzani R. Growth factors, CD34 positive cells, and fibrin network analysis in concentrated growth factors fraction. Microsc Res Tech. 2011 Aug;74(8):772-7. doi: 10.1002/jemt.20968.
Results Reference
background
PubMed Identifier
25028685
Citation
Nahlieli O. Dynamic implant valve approach for dental implant procedures. Chin J Dent Res. 2014;17(1):15-21.
Results Reference
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Graftless Maxillary Sinus Augmentation With CGF Utilizing DIVA System

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