XiVE® CAD/CAM Bridges (Abutment-supported/ Implant-supported) | Completed
XiVE® CAD/CAM Bridges (Abutment-sup... | Completed
XiVE® CAD/CAM Bridges (Abutment-supported/ Implant-supported)
XiCC

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Medical Conditions
  • Partly Edentulous Maxilla
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01522365
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
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.
Research Details
  • 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.
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Device : Abutment-supported XiVE CAD/CAM bridge, Device : Implant-supported XiVE CAD/CAM bridge

Study Arm Groups : Abutment-supported XiVE CAD/CAM bridge, Implant-supported XiVE CAD/CAM bridge

Intervention Type
See Interventions above
Primary Outcome Measures
    Mean change of bone level; 0, 12, 24 months
Secondary Outcome Measures
    Sulcus-fluid-flow-rate; 6 weeks, 6, 12, 24 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
20
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Birmingham
B4 6NN
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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.
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
DF0909-1-272-1x-1
Sponsor(s)
Dentsply Implants Manufacturing GmbH
Key Dates

Recruitment Start Date

Nov 2011

Recruitment End Date

Aug 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

23 Jan 2012

Date updated in source

28 Aug 2018