Clinical Investigation to Assess the Safety and Feasibility of the Crestal, Minimal-invasive Sinus Floor Augmentation With the Pressure Chamber Drill (DKK) and the Sinus Vibration Pump (SVP) (DKK SVP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Jeder GmbH.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Jeder GmbH
ClinicalTrials.gov Identifier:
NCT01204424
First received: September 16, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

The success of dental implants is based on a variety of factors including; surgical technique, health of the patient, operator skill and, to a significant part, sufficient bone for the placement and integration of dental implants. To that end, the replacement of the maxillary posterior teeth have presented a considerable challenge because, after the loss of maxillary posterior teeth the quality and quantity of the remaining supporting bone may be insufficient to support implants properly or reliably. To overcome the deficiency of insufficient vertical bone mass of the maxilla, several surgical techniques have been developed to increase available bone mass for the replacement of dental implants by bone augmentation.

The conventional procedure for a sinus lift (Caldwell-Luc procedure) requires preparation of a mucoperiosteal flap in the buccal molar region and to cut an oval window in the thus exposed bone, without damage to the subjacent maxillary sinus membrane. The procedure is very invasive and subjects the patient to great stress as a result of substantial swelling and discoloration of up to 10 days, and possibly of pain. This surgical procedure is oftentimes referred to as "open" or "classic" sinus lift. This technique is fraught with many risks and complications because of the limitations of healing potential in the maxillary sinus. In spite of these risks many patients undergo this procedure because of the strong desire to replace missing maxillary teeth with dental implants.

An alternative approach to the maxillary sinus from the inferior approach of the alveolar ridge utilizing solid cylindrical osteotomes was described by Dr. Summers (crestal sinus lift). It is a more conservative approach and is less invasive. It was developed to eliminate the risks described above.While this technique is safer, an overzealous use of an osteotome during the placement of the regenerative material can result in the perforation of the subantral membrane with disadvantages discussed above.

Dr. Eder has developed an innovative way - the JEDER System - of carrying out a crestal sinus lift that substantially reduces the risk of perforating the subantral membrane. This minimal- invasive way uses 2 newly developed and successfully patented instruments, the "Druckkammerknochenfräse" DKK and the "Sinusvibrationspumpe" SVP. Following JEDER Syst. the mucous membrane of the mouth is opened from the toothless part of the maxillary crest up to the bone and the bone is scraped by a cylindrical cutter in the shape of a tunnel up to slightly underneath the maxillary sinus membrane.

The aim of the study is to assess the efficacy and safety of the JEDER Syst., which was already demonstrated in 50 treatment attempts. The results of this study will be used for the certification process to enable the declaration of conformity for the market approval.

The main outcome parameter is the perforation rate of the subantral membrane intraoperatively and within 6 weeks after the operation.

Risk benefit assessment:

In the present study there will be no additional examinations undertaken compared to patients which undergo the conventional procedure. The conventional procedure is associated with a risk of membrane perforation and consecutive diseases like infection, swelling and pain. All these inconveniences should be avoided by using the JEDER Syst. If the worst case scenario - the perforation of the subantral membrane - happens, the conventional method will be used. Therefore, the risk-benefit assessment


Condition Intervention Phase
Insufficient Bone Mass in the Maxilla for Dental Implants
Device: minimal-invasive sinus floor augmentation with the DKK and SVP (JEDER Syst.)
Device: minimal invasive crestal sinus lift with the JEDER Systh.
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Klinische Prüfung Zur Untersuchung Der Sicherheit Und Machbarkeit Des Crestalen, Minimal-invasiven Kieferknochenaufbaus (Sinuslift) Mit Der Druck-kammerknochenfräse (DDK) Und Der Sinusvibrationspumpe (SVP)

Resource links provided by NLM:


Further study details as provided by Jeder GmbH:

Primary Outcome Measures:
  • perforation rate of the subantral membrane in the sinus maxillaris [ Time Frame: intraoperativ and within 6 weeks after the operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: minimal-invasive sinus floor augmentation with the DKK and SVP (JEDER Syst.)
    minimal-invasive sinus floor augmentation with the DKK and SVP (JEDER Syst.)
    Device: minimal invasive crestal sinus lift with the JEDER Systh.

    The mucous membrane is opened from the toothless part of the maxillary crest up to the bone and the bone is scraped by a cylindrical cutter in the shape of a tunnel up to slightly underneath the maxillary sinus membrane and hydraulic pressure is being built up within the DKK. A centrally placed drill within the DKK slowly moves in the direction of the membrane. At the moment of the first minimal perforation of the remaining bone the pressurized fluid pushes the membrane back and ensures that the membrane is not perforated by the drill.

    The SVP is used to generate hydraulic vibrations, which help to further raise the membrane from the bone (principle of the "percussion drill"). After the maxillary sinus membrane has successfully been elevated, the working fluid is extracted and bone replacement material is introduced via the bore.

    Other Name: minimal invasive crestal sinuslift
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • demand for sinus floor elevation (regio 4 to 7)
  • loss of teeth (regio 4 to 7)
  • needed extraction of teeth (regio 4 to 7)

Exclusion Criteria:

  • maxillary bone mass <3mm
  • severe chronic illness or immune deficiency
  • cortisone therapy
  • sinus membrane membrane hight >5mm
  • chronic sinusitis
  • smoking >20 Zigarettes
  • missing dental hygiene
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204424

Contacts
Contact: Andreas Bayerle, MBA abayerle@yahoo.com
Contact: Michaela Bayerle-Eder, Prof., michaela.bayerle-eder@meduniwien.ac.at

Locations
Austria
Ordination Dr. Klaus Eder Recruiting
Vienna,, Vienna, Austria, 1130
Sponsors and Collaborators
Jeder GmbH
Investigators
Study Director: Michaela M Bayerle-Eder, Prof., MD, MBA Medical University Vienna, Vienna Austria, Europe
  More Information

No publications provided

Responsible Party: Andreas Bayerle, CEO, JEDER GmbH
ClinicalTrials.gov Identifier: NCT01204424     History of Changes
Other Study ID Numbers: DKK-SVP-10 Prot. 1.4, EK_10_101_0610
Study First Received: September 16, 2010
Last Updated: September 16, 2010
Health Authority: Austria: AGES Agentur für Gesundheit und Ernährungssicherheit in Österreich

Keywords provided by Jeder GmbH:
minimal invasive
sinus floor augmentation
sinuslift
dental implants

ClinicalTrials.gov processed this record on August 28, 2014