Partly Edentulous MaxillaXiCCNCT01522365
XiVE® CAD/CAM Bridges (Abutment-supported/ Implant-supported)
A study testing Abutment-supported XiVE CAD/CAM bridge and Implant-supported XiVE CAD/CAM bridge in people with Partly Edentulous Maxilla, run by Dentsply Implants Manufacturing GmbH at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partly Edentulous Maxilla
- What is being tested?
- Abutment-supported XiVE CAD/CAM bridge and Implant-supported XiVE CAD/CAM bridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Oct 2010to 8 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham, School of dentistry
Birmingham, B4 6NN
About this study
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.
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.
Read the 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.
- Conditions
- Partly Edentulous Maxilla
- Being tested
- Abutment-supported XiVE CAD/CAM bridge, Implant-supported XiVE CAD/CAM bridge
- Keywords
- Dental implants, XiVE CAD/CAM bridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abutment-supported XiVE CAD/CAM bridgeDevice
One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment
Implant-supported XiVE CAD/CAM bridgeDevice
One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Implant-supported XiVE CAD/CAM bridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 12, 24 months
Secondary outcomes (1)
Sulcus-fluid-flow-rate
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 an electronic sulcus fluid hygrometer, and always as the first procedure in order not to be influenced by other investigation parameters.
The hydrometer values results are generally classified in the categories healthy (0-20), slightly irritated (21-40), moderately irritated (< 100) and strongly inflamed (> 100). For this clinical investigation no absolute values, but relative values were compared. The SFFR values measured for each implant at Visit 1 were defined as "zero point-values". The respective first natural tooth in mesial direction served as control.
All values obtained at the following visits for each implant were compared to the appropriate reference value (zero point).
Measured: 6 weeks, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study start7 Oct 2010
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Partly Edentulous MaxillaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth design, i.e. each subject have both treatment arms.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Implants Manufacturing GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manfred Wichmann, Prof. Dr., Principal investigator, Erlangen University HospitalThomas Dietrich, Prof. Dr. Dr., Principal investigator, Birmingham University, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522365
- Sponsor's protocol ID
- DF0909-1-272-1x-1
- Acronym
- XiCC
- Status last verified
- Aug 2022
- First submitted
- 23 Jan 2012
- Last updated
- 13 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01522365
- Acronym / sponsor ID
- XiCC / DF0909-1-272-1x-1
- Conditions
- Partly Edentulous Maxilla
- Keywords
- Dental implants, XiVE CAD/CAM bridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dentsply Implants Manufacturing GmbHIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2010 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Posted 13 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-mouth design, i.e. each subject have both treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Abutment-supported XiVE CAD/CAM bridge | Active comparator | Device: Abutment-supported XiVE CAD/CAM bridgeAfter randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed on an abutment. |
| Implant-supported XiVE CAD/CAM bridge | Active comparator | Device: Implant-supported XiVE CAD/CAM bridgeAfter randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed directly on an implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abutment-supported XiVE CAD/CAM bridgeOne side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment | Device | Abutment-supported XiVE CAD/CAM bridge |
| Implant-supported XiVE CAD/CAM bridgeOne side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant | Device | Implant-supported XiVE CAD/CAM bridge |
Primary outcome
Mean Change of Bone Level
Time frame: 0, 12, 24 months
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.
1 secondary outcome
Sulcus-fluid-flow-rate
Time frame: 6 weeks, 6, 12, 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Wichmann, Prof. Dr. principal investigator
Erlangen University Hospital
Thomas Dietrich, Prof. Dr. Dr. principal investigator
Birmingham University, School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abutment-supported XiVE CAD/CAM bridge and Implant-supported XiVE CAD/CAM bridge in people with Partly Edentulous Maxilla, run by Dentsply Implants Manufacturing GmbH at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change of Bone Level (time frame: 0, 12, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.