Dental Implant Failure NosNCT03041584
Dental Implants Placed by Using a Drill Guide Versus Non-guided Placement. Follow-up Study
A study testing Guided placement, Non-guided placement and Astra Tech TX implant in people with Dental Implant Failure Nos, run by KU Leuven.
Trial summary
To assess implant outcomes, both clinical and radiological, in a randomized study on guided implant placement after 3-year follow-up, compared to non-guided treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failure Nos
- What is being tested?
- Guided placement, Non-guided placement and Astra Tech TX implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jun 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
- An age of at least 18 year
- Extraction socket healing for at least 6 months
Who cannot join
- Unlikely to be able to comply with study procedures
- History of intravenous bisphosphonate treatment
- Medical history that makes implant insertion unfavorable
- Current pregnancy
- Present alcohol and/or drug abuse
- Major systemic diseases
Show all 9Show fewer
- Untreated, uncontrolled caries and/or periodontal disease
- History of local irradiation
- Need for bone grafting and/or sinus lift in the planned implant area
About this study
Official title: Implant-centered Outcomes of Guided Surgery, a 3-year Follow-up: An RCT Comparing Guided Surgery With Non-guided Implant Placement
To assess implant outcomes, both clinical and radiological, in a randomized study on guided implant placement after 3-year follow-up, compared to non-guided treatment.
- Conditions
- Dental Implant Failure Nos
- Being tested
- Guided placement, Non-guided placement, Astra Tech TX implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided placementProcedure or surgery
implant placement with use of guide
Non-guided placementProcedure or surgery
conventional implant placement
Astra Tech TX implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Materialise Universal®/ mucosa (Mat Mu) | Experimental | Not described Receives: Procedure: Guided placement; Device: Astra Tech TX implant |
| Materialise Universal®/ bone (Mat Bo) | Experimental | Not described Receives: Procedure: Guided placement; Device: Astra Tech TX implant |
| FacilitateTM/ mucosa (Fac Mu) | Experimental | Not described Receives: Procedure: Guided placement; Device: Astra Tech TX implant |
| FacilitateTM/ bone (Fac Bo) | Experimental | Not described Receives: Procedure: Guided placement; Device: Astra Tech TX implant |
| mental navigation (Mental) | Active comparator | Not described Receives: Procedure: Non-guided placement; Device: Astra Tech TX implant |
| pilot-drill template (Templ) | Active comparator | Not described Receives: Procedure: Non-guided placement; Device: Astra Tech TX implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic outcome
Bone loss in mm
Measured: Change between baseline and 3 Year
Secondary outcomes (3)
probing pocket depth
measurement in mm of pocket around implant, 4 per implant
Measured: Change between baseline and 3 Year
bleeding on probing
measurement of presence of bleeding on probing, Yes =1, No=0. 4 per implant
Measured: Change between baseline and 3 Year
plaque
measurement of presence of plaque, Yes =1, No=0. 4 per implant
Measured: Change between baseline and 3 Year
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 startJan 2009
- Primary completionJun 2012
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant Failure NosStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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
- NCT03041584
- Sponsor's protocol ID
- B32220095376
- 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
- Implant-centered Outcomes of Guided Surgery, a 3-year Follow-up: An RCT Comparing Guided Surgery With Non-guided Implant Placement
- ClinicalTrials.gov ID
- NCT03041584
- Acronym / sponsor ID
- B32220095376
- Conditions
- Dental Implant Failure Nos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- Jan 2009 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 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 assess implant outcomes, both clinical and radiological, in a randomized study on guided implant placement after 3-year follow-up, compared to non-guided treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Materialise Universal®/ mucosa (Mat Mu) | Experimental | Procedure: Guided placement, Device: Astra Tech TX implant |
| Materialise Universal®/ bone (Mat Bo) | Experimental | Procedure: Guided placement, Device: Astra Tech TX implant |
| FacilitateTM/ mucosa (Fac Mu) | Experimental | Procedure: Guided placement, Device: Astra Tech TX implant |
| FacilitateTM/ bone (Fac Bo) | Experimental | Procedure: Guided placement, Device: Astra Tech TX implant |
| mental navigation (Mental) | Active comparator | Procedure: Non-guided placement, Device: Astra Tech TX implant |
| pilot-drill template (Templ) | Active comparator | Procedure: Non-guided placement, Device: Astra Tech TX implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent
- An age of at least 18 year
- Extraction socket healing for at least 6 months
Key exclusion criteria (9 listed)
- Unlikely to be able to comply with study procedures
- History of intravenous bisphosphonate treatment
- Medical history that makes implant insertion unfavorable
- Current pregnancy
- Present alcohol and/or drug abuse
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 |
|---|---|---|
| Guided placementimplant placement with use of guide | Procedure or surgery | FacilitateTM/ bone (Fac Bo), FacilitateTM/ mucosa (Fac Mu), Materialise Universal®/ bone (Mat Bo), Materialise Universal®/ mucosa (Mat Mu) |
| Non-guided placementconventional implant placement | Procedure or surgery | mental navigation (Mental), pilot-drill template (Templ) |
| Astra Tech TX implant | Device | FacilitateTM/ bone (Fac Bo), FacilitateTM/ mucosa (Fac Mu), Materialise Universal®/ bone (Mat Bo), Materialise Universal®/ mucosa (Mat Mu), mental navigation (Mental), pilot-drill template (Templ) |
Primary outcome
Radiographic outcome
Time frame: Change between baseline and 3 Year
Bone loss in mm
3 secondary outcomes
probing pocket depth
Time frame: Change between baseline and 3 Year
bleeding on probing
Time frame: Change between baseline and 3 Year
plaque
Time frame: Change between baseline and 3 Year
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
Related trials for Dental Implant Failure Nos
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Recruiting
Clinical Efficacy of Nobel Parallel CC Implants With on1 Abutment in Posterior Area Participants
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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 Guided placement, Non-guided placement and Astra Tech TX implant in people with Dental Implant Failure Nos, 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 3 inclusion and 9 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?
Radiographic outcome (time frame: Change between baseline and 3 Year). 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.