Graftless Maxillary Sinus Augmentation With CGF Utilizing DIVA System

Alveolar Bone Loss Clinical Trial

Official title:

Graftless Maxillary Sinus Augmentation With CGF Utilizing DIVA System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02985645
• Other study ID #: 0153-16-NHR
• Status: Not yet recruiting
• Phase: N/A
• First received: November 26, 2016
• Last updated: December 6, 2016
• Start date: December 2016
• Est. completion date: January 2018

Study information

• Verified date: December 2016
• Source: Western Galilee Hospital-Nahariya
• Contact: Ruth Angel-Dar, Dr.
• Phone: +972-4-9107076
• Email: rutiangel123[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

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.

Locations

Country	Name	City	State
Israel	Western Galilee Medical Center	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

References & Publications (9)

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. Review. — View 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. Review. — View 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. — View Citation

Nahlieli O. Dynamic implant valve approach for dental implant procedures. Chin J Dent Res. 2014;17(1):15-21. — View Citation

Rodella LF, Favero G, Boninsegna R, Buffoli B, Labanca M, Scarì 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. — View 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. — View 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. — View 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. — View Citation

Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	one year	No
Secondary	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.	one year	No