Implant ComplicationNCT03041597
Dental Implant Supported Removable Dental Prostheses
A study testing placement of implants, immediate loading and conventional loading in people with Implant Complication and Prosthesis Survival, run by KU Leuven.
Trial summary
To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed versus immediate loading, using abutments with the SynCone® concept for implant-supported detachable dental prosthesis (ISDDP) in the edentulous upper jaw. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Complication, Prosthesis Survival
- What is being tested?
- placement of implants, immediate loading and conventional loading
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2009to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Extraction sockets should have healed at least 4 months
- Sufficient bone volume to place six implants in the maxilla
- No previous bone augmentation procedures
- The mandible can have any kind of dentition as long as a well-distributed contact relationship with the new prosthesis in the maxilla can be established.
- Accepting to comply with study procedures
Who cannot join
- Physical or psychological disorders prohibiting implant treatment
- Heavy smoking (>10 cigarettes/day)
- Present alcohol and/or drug abuse
- Physical handicap that may interfere with the ability to perform oral hygiene
About this study
Official title: An Randomized Controlled Trial Comparing Immediate Loading With Conventional Loading Using Cone-anchored Implant Supported Removable Dental Prostheses, a Two Year Follow up
To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed versus immediate loading, using abutments with the SynCone® concept for implant-supported detachable dental prosthesis (ISDDP) in the edentulous upper jaw.
- Conditions
- Implant Complication, Prosthesis Survival
- Being tested
- placement of implants, immediate loading, conventional loading, Ankylos implant
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement of implantsProcedure or surgery
surgical procedure and placement of implants
immediate loadingProcedure or surgery
cone-anchored implant supported removable dental prostheses placement
conventional loadingProcedure or surgery
cone-anchored implant supported removable dental prostheses placement in 3mo
Ankylos implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Immediate loading | Experimental | Not described Receives: Procedure: placement of implants; Procedure: immediate loading; Device: Ankylos implant |
| delayed loading | Active comparator | Not described Receives: Procedure: placement of implants; Procedure: conventional loading; Device: Ankylos implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone loss
measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.
Measured: Difference between loading and Year two
Secondary outcomes (3)
probing pocket depth
Measurement in mm, 4 sites per implant.
Measured: Difference between loading and Year two
plaque
presence of plaque, 4 sites per implant, Yes=1 or No=0
Measured: Difference between loading and Year two
bleeding on probing
presence of bleeding on probing, 4 sites per implant, Yes=1 or No=0
Measured: Difference between loading and Year two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Sep 2009
- Primary completion31 Dec 2013
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Principal investigator, Lauren Bernard, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041597
- Sponsor's protocol ID
- B32220096198
- Status last verified
- Feb 2017
- First submitted
- 26 Jan 2017
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Randomized Controlled Trial Comparing Immediate Loading With Conventional Loading Using Cone-anchored Implant Supported Removable Dental Prostheses, a Two Year Follow up
- ClinicalTrials.gov ID
- NCT03041597
- Acronym / sponsor ID
- B32220096198
- Conditions
- Implant Complication, Prosthesis Survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed versus immediate loading, using abutments with the SynCone® concept for implant-supported detachable dental prosthesis (ISDDP) in the edentulous upper jaw.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate loading | Experimental | Procedure: placement of implants, Procedure: immediate loading, Device: Ankylos implant |
| delayed loading | Active comparator | Procedure: placement of implants, Procedure: conventional loading, Device: Ankylos implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of informed consent
- Extraction sockets should have healed at least 4 months
- Sufficient bone volume to place six implants in the maxilla
- No previous bone augmentation procedures
- The mandible can have any kind of dentition as long as a well-distributed contact relationship with the new prosthesis in the maxilla can be established.
Key exclusion criteria (4 listed)
- Physical or psychological disorders prohibiting implant treatment
- Heavy smoking (>10 cigarettes/day)
- Present alcohol and/or drug abuse
- Physical handicap that may interfere with the ability to perform oral hygiene
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 |
|---|---|---|
| placement of implantssurgical procedure and placement of implants | Procedure or surgery | Immediate loading, delayed loading |
| immediate loadingcone-anchored implant supported removable dental prostheses placement | Procedure or surgery | Immediate loading |
| conventional loadingcone-anchored implant supported removable dental prostheses placement in 3mo | Procedure or surgery | delayed loading |
| Ankylos implant | Device | Immediate loading, delayed loading |
Primary outcome
bone loss
Time frame: Difference between loading and Year two
measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.
3 secondary outcomes
probing pocket depth
Time frame: Difference between loading and Year two
plaque
Time frame: Difference between loading and Year two
bleeding on probing
Time frame: Difference between loading and Year two
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing placement of implants, immediate loading and conventional loading in people with Implant Complication and Prosthesis Survival, run by KU Leuven.
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 6 inclusion and 4 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
bone loss (time frame: Difference between loading and Year two). 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 3 Feb 2017; AzTrials last refreshed its copy on 6 Nov 2026.