Graftless Maxillary Sinus Augmentation With CGF Utilizing DIVA System
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedDecember 8, 2016
December 1, 2016
1 year
November 26, 2016
December 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Quantification of growth factors released from the CGF matrix in vitro
one year
Study Arms (1)
Treatment
EXPERIMENTALmaxillary sinus augmentation with CGF
Interventions
Graftless maxillary sinus augmentation surgery with CGF application utilizing DIVA system
The DIVA system will be used to apply the CGF to the maxillary sinus.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western Galilee Medical Center
Nahariya, Israel
Related Publications (9)
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.
PMID: 22082056BACKGROUNDTatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
PMID: 3516738BACKGROUNDSummers 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.
PMID: 7994726BACKGROUNDDanesh-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.
PMID: 27235382BACKGROUNDFalah 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.
PMID: 27256011BACKGROUNDSohn 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.
PMID: 20523182BACKGROUNDSohn 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.
PMID: 21881519BACKGROUNDRodella 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.
PMID: 21780251BACKGROUNDNahlieli O. Dynamic implant valve approach for dental implant procedures. Chin J Dent Res. 2014;17(1):15-21.
PMID: 25028685BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Samer Srouji, Prof.
Western Galilee Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 26, 2016
First Posted
December 7, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2017
Study Completion
January 1, 2018
Last Updated
December 8, 2016
Record last verified: 2016-12