Implant Tissue FailurePhase 4IONENCT04139512
One-abutment One-time for Immediate Restoration Procedure in the Esthetic Zone
A Phase 4 study testing guided surgery and conventionnel implant placement in people with Implant Tissue Failure, run by University of Liege at 1 site in Belgium.
Trial summary
Objectives: The aim of this randomized control trial was to compare immediate restoration procedure with a one abutment one-time technique using a conventional versus full digital workflow. Surgical accuracy, provisional fit and patient reported outcome measures (PROMs) of. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Tissue Failure
- What is being tested?
- guided surgery and conventionnel implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2018to 1 Aug 2019
- Phase
- Phase 4
- 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
- Subjects must have voluntarily signed the informed consent form before any study related action
- Age > 18 years old
- Single missing tooth or 2 non-adjacent missing teeth in the aesthetic area of the upper jaw. Patients who require an extraction and immediate implant placement can be included.
- Men/women
- Good systemic health (ASA I/II)
- No contra indication against oral surgical interventions
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- At least 10 mm in the vertical dimension
- At least 7 mm in the bucco-palatal dimension
- No need for simultaneous bone augmentation procedure. However, a bone augmentation could have been realized 4 months prior to the digital planning of the surgery
- Healthy periodontal condition and full mouth plaque score (FMPS) lower or equal than 25%
Who cannot join
- Autoimmune disease requiring medical treatment
- Medical conditions requiring prolonged use of steroids
- Use of bisphosphonates intravenously or more than 3 years of oral use
- Infection (local or systemic) Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection will undergo a medical treatment prior to its entrance to the study.
- In case of systemic infection, the evaluation will be based on medical anamneses and, if necessary, will be referred to relevant medical tests.
- Current pregnancy or breastfeeding women
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- Alcoholism or chronically drug abuse
- Immunocompromised patients
- Uncontrolled diabetes
- Smokers, more than 10 cigarettes per day
- Local exclusion criteria
- Untreated local inflammation
- Mucosal disease or oral lesions
- History of local irradiation therapy in the head-neck area
- Persistent intraoral infection
- Patients with bad oral hygiene or unmotivated for normal home care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-abutment One-time for Immediate Restoration Procedure in the Esthetic Zone: A Randomized Controlled Trial Comparing Conventional Versus Full Digital Workflow
Objectives: The aim of this randomized control trial was to compare immediate restoration procedure with a one abutment one-time technique using a conventional versus full digital workflow. Surgical accuracy, provisional fit and patient reported outcome measures (PROMs) of.
Read the detailed description
Objectives: The aim of this randomized control trial was to compare immediate restoration procedure with a one abutment one-time technique using a conventional versus full digital workflow. Surgical accuracy, provisional fit and patient reported outcome measures (PROMs) of.
Material and method: Sites with single edentulous spaces and neighboring natural teeth were randomized into static computer-aided implant surgery (s-CAIS) or freehand placement implant surgery groups. In both groups, digital implant planning was performed using data from cone beam computed tomography (CBCT) and surfaces scans. In the s-CAIS group, a surgical guide was produced and used for fully guided implant surgery, while in the freehand group, the implants were placed in a freehand manner. the deviations in angles, shoulders and apexes between planned and actual implant positions were measured based on postoperative optic impressions. In the test group, a custom-made zirconia abutment and a provisional restoration were immediately placed using a full digital workflow whereas in the control group, a physical impression was taken, and the abutment and crown were placed 10 days post-surgery. Loading outcomes (interproximal contact, occlusal contact, white esthetic score (WES)) were assessed as the PROMs.
- Conditions
- Implant Tissue Failure
- Being tested
- guided surgery, conventionnel implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided surgeryProcedure or surgery
placement of implant with local anesthesia using full guided surgery protocol versus free- hande one
conventionnel implant placementProcedure or surgery
placement of dental implant with conventionnal freehand technic
| Study group | Role | What they receive |
|---|---|---|
| guided surgery | Other | test group, using a full digital workflow procedure Receives: Procedure: guided surgery |
| conventional technic | Other | free- hand technic to place implant Receives: Procedure: conventionnel implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the surgical accuracy
The STL files (stereolithography files) were superimposed with pre-operative CBCT (Cone beam computed tomography) images using automated surface best fit matching with the iterative closest point algorithm in the treatment evaluation mode, coDiagnostiX® software version 9.7 (Dental Wings Inc). The mean deviations at the implant shoulder and apex between the planned and actual implant positions were measured in millimeters (mm), as well as the divergence of the implant axis in degrees. All measurements were performed by a single dentist, who conducted the virtual implant planning in all cases.
Measured: The day of the surgery
Clinical fit of the provisional restoration measurements
The measurements were based on the adaptation of the provisional crown. Interproximal contacts were evaluated according to the criteria described by Syrek (Syrek et al., 2010). Dental floss (Johnson \& Johnson Reach®, Waxed dentotape, New Brunswick, NJ, USA) was used to check the interproximal contact. A score from 1 to 4 was given to the fitting criteria (the higher the score, the better the adaptation).
Measured: 10 days post surgery
Secondary outcomes (2)
WES
To evaluate the esthetic outcomes of the provisional crown, the White Esthetic Score (WES) was reported. The highest WES score was 10, which represented a close match with the clinical single-tooth crown present at the contralateral natural tooth or neighboring teeth. The WES was evaluated by a blinded prosthodontic, based on photography.
Measured: 10 days post surgery
Patient-reported outcomes measures (PROMs)
PROMs were obtained using a VAS form immediately after the immediate restoration of the implant. Five questions were used:
- Do you feel your provisional tooth as a natural tooth? (0 = not at all to 10, absolutely).
- Do you find your provisional tooth looks like a natural tooth? (0 = not at all to 10, absolutely).
- How much discomfort did you feel during the physical impression? (0 = little or 10, a lot) for the control group. How much discomfort did you feel during the optical impression? (0 = little to 10, a lot) for the test group.
- Would you be willing to undergo this treatment again? (0= not at all to 10, absolutely).
- Are you satisfied with the aesthetics outcomes of your provisional tooth. (0 = not at all to 10, absolutely).
Measured: 10 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Jun 2018
- Primary completion1 Jun 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Tissue FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study was designed as a randomized controlled trial comparing immediate restoration procedure in the esthetic zone with a one abutment one-time technique and using a conventional (control group) versus full digital workflow (test group),
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. France LAMBERT, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139512
- Sponsor's protocol ID
- B707201731117
- Acronym
- IONE
- Status last verified
- Oct 2019
- First submitted
- 19 Aug 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-abutment One-time for Immediate Restoration Procedure in the Esthetic Zone: A Randomized Controlled Trial Comparing Conventional Versus Full Digital Workflow
- ClinicalTrials.gov ID
- NCT04139512
- Acronym / sponsor ID
- IONE / B707201731117
- Conditions
- Implant Tissue Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 25 Oct 2019 (actual)
- 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.
Objectives: The aim of this randomized control trial was to compare immediate restoration procedure with a one abutment one-time technique using a conventional versus full digital workflow. Surgical accuracy, provisional fit and patient reported outcome measures (PROMs) of.
Detailed description
Objectives: The aim of this randomized control trial was to compare immediate restoration procedure with a one abutment one-time technique using a conventional versus full digital workflow. Surgical accuracy, provisional fit and patient reported outcome measures (PROMs) of.
Material and method: Sites with single edentulous spaces and neighboring natural teeth were randomized into static computer-aided implant surgery (s-CAIS) or freehand placement implant surgery groups. In both groups, digital implant planning was performed using data from cone beam computed tomography (CBCT) and surfaces scans. In the s-CAIS group, a surgical guide was produced and used for fully guided implant surgery, while in the freehand group, the implants were placed in a freehand manner. the deviations in angles, shoulders and apexes between planned and actual implant positions were measured based on postoperative optic impressions. In the test group, a custom-made zirconia abutment and a provisional restoration were immediately placed using a full digital workflow whereas in the control group, a physical impression was taken, and the abutment and crown were placed 10 days post-surgery. Loading outcomes (interproximal contact, occlusal contact, white esthetic score (WES)) were assessed as the PROMs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The present study was designed as a randomized controlled trial comparing immediate restoration procedure in the esthetic zone with a one abutment one-time technique and using a conventional (control group) versus full digital workflow (test group),
| Arm | Type | Receives |
|---|---|---|
| guided surgery | Other | Procedure: guided surgerytest group, using a full digital workflow procedure |
| conventional technic | Other | Procedure: conventionnel implant placementfree- hand technic to place implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must have voluntarily signed the informed consent form before any study related action
- Age > 18 years old
- Single missing tooth or 2 non-adjacent missing teeth in the aesthetic area of the upper jaw. Patients who require an extraction and immediate implant placement can be included.
- Men/women
- Good systemic health (ASA I/II)
Key exclusion criteria (16 listed)
- Autoimmune disease requiring medical treatment
- Medical conditions requiring prolonged use of steroids
- Use of bisphosphonates intravenously or more than 3 years of oral use
- Infection (local or systemic) Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection will undergo a medical treatment prior to its entrance to the study.
- In case of systemic infection, the evaluation will be based on medical anamneses and, if necessary, will be referred to relevant medical tests.
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 surgeryplacement of implant with local anesthesia using full guided surgery protocol versus free- hande one | Procedure or surgery | guided surgery |
| conventionnel implant placementplacement of dental implant with conventionnal freehand technic | Procedure or surgery | conventional technic |
Primary outcome
Assessment of the surgical accuracy
Time frame: The day of the surgery
The STL files (stereolithography files) were superimposed with pre-operative CBCT (Cone beam computed tomography) images using automated surface best fit matching with the iterative closest point algorithm in the treatment evaluation mode, coDiagnostiX® software version 9.7 (Dental Wings Inc). The mean deviations at the implant shoulder and apex between the planned and actual implant positions were measured in millimeters (mm), as well as the divergence of the implant axis in degrees. All measurements were performed by a single dentist, who conducted the virtual implant planning in all cases.
Clinical fit of the provisional restoration measurements
Time frame: 10 days post surgery
The measurements were based on the adaptation of the provisional crown. Interproximal contacts were evaluated according to the criteria described by Syrek (Syrek et al., 2010). Dental floss (Johnson \& Johnson Reach®, Waxed dentotape, New Brunswick, NJ, USA) was used to check the interproximal contact. A score from 1 to 4 was given to the fitting criteria (the higher the score, the better the adaptation).
2 secondary outcomes
WES
Time frame: 10 days post surgery
Patient-reported outcomes measures (PROMs)
Time frame: 10 days post surgery
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 25 Oct 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing guided surgery and conventionnel implant placement in people with Implant Tissue Failure, run by University of Liege at 1 site in Belgium.
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 16 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 25 Oct 2019. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessment of the surgical accuracy (time frame: The day of the surgery). The study lists 2 primary outcomes in all. 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 25 Oct 2019.