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

NCT01522365 | Completed Results

• 1 other identifier: DF0909-1-272-1x-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Partly Edentulous Maxilla

Keywords

Dental implants; XiVE CAD/CAM bridge

Outcome Measures

Primary Outcomes (1)

• Mean Change of Bone Level

  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.

  0, 12, 24 months

Secondary Outcomes (1)

• Sulcus-fluid-flow-rate

  6 weeks, 6, 12, 24 months

Study Arms (2)

Abutment-supported XiVE CAD/CAM bridge

ACTIVE COMPARATOR

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

Implant-supported XiVE CAD/CAM bridge

ACTIVE COMPARATOR

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

Interventions

Abutment-supported XiVE CAD/CAM bridge DEVICE

One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment

Abutment-supported XiVE CAD/CAM bridge

Implant-supported XiVE CAD/CAM bridge DEVICE

One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant

Implant-supported XiVE CAD/CAM bridge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dentsply Implants Manufacturing GmbH: lead

Study Sites (1)

University of Birmingham, School of dentistry

Birmingham, B4 6NN, United Kingdom

Location

Results Point of Contact

• Title: Director Center of Clinical Research, AnnaKarin Lundgren
• Organization: Dentsply Sirona Implants

clinicalresearchmolndal@dentsplysirona.com

+46 (0)31 376 30 00

Study Officials

• Manfred Wichmann, Prof. Dr.

  Erlangen University Hospital

  PRINCIPAL INVESTIGATOR

• Thomas Dietrich, Prof. Dr. Dr.

  Birmingham University, School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split-mouth design, i.e. each subject have both treatment arms.

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 31, 2012
• Study Start: October 7, 2010
• Primary Completion: August 8, 2017
• Study Completion: August 8, 2017
• Last Updated: September 13, 2022
• Results First Posted: September 13, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)