XiVE® CAD/CAM Bridges (Abutment-supported/ Implant-supported) (XiCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants Manufacturing GmbH
ClinicalTrials.gov Identifier:
NCT01522365
First received: January 23, 2012
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

This study has been designed in order to collect data with regards to the peri-implant tissue outcome of abutment-supported restoration and direct implant-fixed restoration. Therefore a small group of subjects with partly edentulous maxilla is selected to show that both techniques are efficient and safe and to show comparable peri-implant tissue outcome for both methods. At the time of impression forming for each centre treatment A (= abutment-supported XiVE® CAD/CAM supra-structure) and B (= direct implant-fixed XiVE® CAD/CAM supra-structure) is assigned to the left and right side of the maxilla by being randomized at the time of impression forming.


Condition Intervention
Partly Edentulous Maxilla
Device: Abutment-supported XiVE CAD/CAM bridge
Device: Implant-supported XiVE CAD/CAM bridge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, International, Multi-center Clinical Study to Evaluate the Peri-implant Tissue Outcome of Abutment-supported XiVE® CAD/CAM Supra-structures and Directly Implant-supported XiVE® CAD/CAM Supra-structures (Split-mouth) in Partly Edentulous Human Subjects.

Further study details as provided by Dentsply Implants Manufacturing GmbH:

Primary Outcome Measures:
  • Mean change of bone level [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: No ]

    Intra-oral radiographs from implant insertion and at time for prosthesis insertion as well as from 1 and 2-year follow-up visits (calculated from the time of loading) should be taken for evaluation of bone level. All radiographs will be examined by an independent dentist.

    For the purpose of this examination XCP film holder (DENTSPLY Rinn, 1212 Abbott Drive, Elgin, Illinois 60123-1819, USA) are individualized for each subject and for each x-ray.



Secondary Outcome Measures:
  • Sulcus-fluid-flow-rate [ Time Frame: 6 weeks, 6, 12, 24 months ] [ Designated as safety issue: No ]
    The evaluation of the sulcus fluid flow rate (SFFR) is a common method for the objective definition of the gingiva inflammation level in clinical research. The SFFR is measured with the electronic sulcus fluid hygrometer, Periotron model 600 A No. 700702 (Harco Electronics Ltd., Canada) and always as the first procedure in order not to be influenced by other investigation parameters.


Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Abutment-supported XiVE CAD/CAM bridge
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed on an abutment.
Device: Abutment-supported XiVE CAD/CAM bridge
One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment
Active Comparator: Implant-supported XiVE CAD/CAM bridge
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed directly on an implant.
Device: Implant-supported XiVE CAD/CAM bridge
One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant

Detailed Description:

The planned study profile is to assess the peri-implant tissue outcome of abutment-supported restoration and direct implant-fixed restoration. Two treatments, Treatment A which is the abutment-fixed supra-structure and Treatment B, the direct implant-fixed restoration, are assessed within the scope of this clinical investigation.

Treatment A: The XiVE® CAD/CAM supra-structure is fixed on abutments. The effect of platform-switching which is discussed intensely in the scientific literature is used in order to shift away the connection between implant and supra-construction (interface) from the implant edge and peri-implant tissue and towards the implant centre. However, the implant-abutment-connection area is a potential entry port for micro-organisms which have direct influence on the state of the peri-implant hard and soft tissue and consequently on the long-term prosthetic and implant success [8]. By using an abutment as a connector between implant and supra-structure implies the generation of one more micro-gap (between supra-structure and abutment) and possible retention of microbial plaque though located above the hard tissue level.

Treatment B: The XiVE® CAD/CAM supra-structure is fixed directly on the implants. In contrary to treatment A, only one entry port (micro-gap) for micro-organisms exists: The interface between supra-construction and implant. So, there is one main point where the initial force has main influence on the implant and the peri-implant tissue [8-10]. Besides, this interface lies directly on the implant shoulder level and by that on the osseous level. There is no displacement of the transitional area to the implant centre.

This study has been designed in order to collect data with regards to the CAD/CAM system used on the DENTSPLY Friadent implant system XiVE®. In particular, the peri-implant tissue outcome of abutment-supported restoration and direct implant-fixed restoration will be evaluated. Therefore a small group of subjects with partly edentulous jaw is selected to show that both techniques are efficient and safe and to demonstrate the non-inferiority with regards to the peri-implant tissue outcome for any of both techniques.

Each subject will receive both treatments, treatment A on the one site of the maxilla and treatment B on the other. The randomization method which finally defines which subject receives one treatment on the left maxilla region and the other on the right maxilla area or vice versa is described in section 5.1.

In conclusion, both treatments might have pros and cons which may affect the peri-implant tissue outcome.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject > 18 years.
  2. Female subject of child-bearing potential must use reliable methods of contraception.
  3. Subject has partly edentulous maxilla (free-end or large gap in posterior area on both sides).
  4. For all implants immobility and clear percussion sound is applicable.
  5. The subject is healthy and compliant with good oral hygiene.
  6. Favorable and stable occlusal relationship between the remaining teeth.
  7. Subject must be reliable, cooperative, and in the opinion of the Investigator, likely to be compliant with study procedures.
  8. Subject provides written informed consent signed and dated prior to entering the study.
  9. Implantation of XiVE® implants at least 3 months ago.
  10. XiVE® implants have been placed primary stable by considering sufficient horizontal and vertical bone dimension.

Exclusion Criteria:

  1. Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous year.
  2. Subject with planned or performed head and neck radiation.
  3. Known unavailability of subject for FU Visit(s).
  4. Subject has - in the opinion of the investigator - any systemic metabolic disorder or bone disorder or is taking medication that compromises or might have compromised post-operative tissue regeneration or osseointegration.
  5. Subject has major bone defects in the implantation area.
  6. Subject is taking medication that compromises or might have compromised post-operative healing and/or osseointegration (e. g. bisphosphonates).
  7. Subject exhibits an oral infection.
  8. Subject has received any investigational drug within 30 days prior to screening.
  9. Severe bruxing.
  10. Subject has a clinically significant or unstable medical or physiological condition.
  11. Female subject is pregnant or lactating or intends to become pregnant during the course of the study.
  12. Subject is not willing to participate in the study or not able to understand the content of the study.
  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: NCT01522365

Locations
Germany
Erlangen University Hospital
Erlangen, Germany, 91054
United Kingdom
University of Birmingham, School of dentistry
Birmingham, United Kingdom, B4 6NN
Sponsors and Collaborators
Dentsply Implants Manufacturing GmbH
Investigators
Principal Investigator: Manfred Wichmann, Prof. Dr. Erlangen University Hospital
Principal Investigator: Thomas Dietrich, Prof. Dr. Dr. Birmingham University, School of Dentistry
  More Information

No publications provided

Responsible Party: Dentsply Implants Manufacturing GmbH
ClinicalTrials.gov Identifier: NCT01522365     History of Changes
Other Study ID Numbers: DF0909-1-272-1x-1
Study First Received: January 23, 2012
Last Updated: May 22, 2014
Health Authority: United Kingdom: National Institute for Health Research

Keywords provided by Dentsply Implants Manufacturing GmbH:
Dental implants
XiVE CAD/CAM bridge

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on October 23, 2014