ImplantNCT04027660
Outcome of Immediate Zirconia Implants
An observational study of Implant, run by Implantology Institute at 1 site in Portugal.
Trial summary
The aim is to study bone and soft tissue response to zirconia immediate implants.Volumetric changes will be measured before tooth extraction and after final crow placement. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant
- What is being tested?
- Immediate Zirconia Dental Implant
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 sitePortugal
- Study dates
- 26 Jan 2019to 26 Aug 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sequential recruiting, middle age, moderate to high income
Who may be able to join
- Patients with a non-restorable tooth schedule for extraction
- Anywhere on the mouth except 3rd molar teeth
- Tooth site with no active infection
- No loss of the buccal, palatal or inter proximal bone
- If chronical apical pathology, the six should be less that 4 mm diameter
- ASA 1 or ASA 2 Patient
- Sings the Informed consent -
Who cannot join
- Site has an active infection
- Periapical lesion Beyond 5 mm
- Bone resorption of buccal, palatal or inter proximal plate beyond 2 mm
- Patient doesn't want an immediate implant
- Patient doesn't want a Zirconia Implant
- ASA 3 or ASA 4 Patient
- Refuse to Sign informed consent -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Volumetric (Hard and Soft Tissue) Alterations in Immediate Zirconia Implants
The aim is to study bone and soft tissue response to zirconia immediate implants.Volumetric changes will be measured before tooth extraction and after final crow placement.
Read the detailed description
Bone remodeling around immediate implants is a reality in clinical and literature arena. much is known about titanium implants but little in zirconia implants
In patients that require a tooth extraction anywhere in the oral cavity except 3rd molars are candidates fo the study. Once clinical conditions are establish and medical clearance is ok, the decision for an immediate implant is taken.
Patient will undergo for an intraoral Scanner (IOS, Trios 3Shape) to get an STL file of the previous situation.
On the day of surgery an atraumatically tooth extraction is performed (without rasing a flap) and a Zirconia implant is inserted on the alveolar socket.
The jumping gap (distance from crystal bone to implant body will be filled with a zenograft type of biomaterial) no sutures or membrane will be used.
A provisional crown or an individualized healing abutment will be placed. After 3 month healing an IOS will be made for crown fabrication and a second STL file generated.
After 15 days final crown will be placed, and 3 month after a 3rd IOS made to get the 3rd and final STL file.
An STL software will then make the correlation between the volume behavior in those 3 stages.
The control group, patients go for tooth extraction but no immediate implant and undergo with a classic protocol for implant placement. In this case the STL files are taken pre-operatory, before implant placement 3 month after tooth extraction, 2 month after implant placement (at final impression level), and 3 month after crown placement.
- Conditions
- Implant
- Being tested
- Immediate Zirconia Dental Implant
- Keywords
- dentistry, zirconia, implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Zirconia Dental ImplantDevice
For the Exposed Group the Intervention will be the following
The Surgical procedure will envolve :
- Administration of Articain 1:200.000
- No flap procedure
- Place a Zirconia Implant on the alveolar post extraction socket
- Place xenograft biomaterial in the jumping gap
- Place a provisional crown/individualized healing abutment
The Prosthodontic procedure will evolve:
- Final Impression with a IOS
- Placement of the Final Crown
- 3 month post crown post op 3 IOS will be made for volumetric evaluation :
- before tooth extraction
- 3 month of Osseointegration for final impression
- 3 month after final crown is placed
Final STL evaluation will be performed on a specialized software for volumetric measurements
| Study group | Role | What they receive |
|---|---|---|
| Exposed Immediate Zirconia Implants | Group Formation : patients that require a tooth extraction and have the following clinical indications to be enrolled in an immediate implant.
1. No Active Infection
2. No loss of buccal plate
3. ASA 1 or ASA 2 Patient
Extraction of the tooth will be performed and in the same clinical act, a zirconia dental implant will be placed toghether with a provisional or an individualized customs healing abutment. The jumping gap will be filled with a xenograft biomaterial.
Final Zirconia Crown delivered 3 month after healing.
3 STL files will be generated - Before extraction, at Final impression level 3 month after implant placement, at 3 month after final prosthesis insertion
Measure 1,2 and 3 will be at the gingival margin(measure 1), at 2mm (measure 2) and 4 mm (measure 3) apical to gingival margin. Both palatal and buccal references are joined by a line that gives a distance.Difference on the dimensions of each line with different time of evaluation represent ridge loss. Receives: Device: Immediate Zirconia Dental Implant | |
| Non-exposed delayed Zirconia implants | Group Formation : patients that require a tooth extraction and have the following clinical indications not to be enrolled in an immediate implant. 1. Active Infection 2. Loss of the buccal plate. Extraction will be performed but a classical implant approach will be made, that include a waiting period of 3 month before implant placement and 3 month after osseointegration period before place final crown. Implant placement with Guided bone regeneration (xenograft), if needed. Final Zirconia Crown 3 month after implant placement. 4 STL files will be generated - Before extraction, before implant placement, at Final impression level 3 month after implant placement, at 3 month after final prosthesis insertion Measure 1,2 and 3 the same has the other group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ridge dimensions (Bone and soft tissue from buccal to palatal) Changes from Implant placement in alveolar extraction sockets (Day 1) to final impression, 2 month after osseointegration (Day 2), in Zirconia Immediate Implants
Physiologic resorption rate (measured in a buccal to palatal dimension) from day 1 - Immediate implant in an alveolar extraction socket to Day 2 - Day of final Impression measured by STL superimposition. Acquisition of STL File with an IOS in both time frames, and in a STL reader software (Geomagic Control X) we merge them with the corresponding common landmarks for a best fit alignment.
Measure include, Total bone and soft tissue volume loss (in cubic centimeters). Bone collapse measured in mm from the most buccal point to most palatal point of the ridge.
Measured: 1 year
Ridge dimensions (Bone and soft tissue from buccal to palatal) Changes from final impression (Day 2 ) to 2 month after osseointegration (Day 3), in Zirconia Immediate Implants
Physiologic resorption rate from Day 2 - Day of final Impression to Day 3- 3 month after final crown insertion measured by STL superimposition. Acquisition of STL File with an IOS in both time frames, and in an STL reader software (Geomagic Control X) we merge them with the corresponding common landmarks for a best fit alignment.
Measure include, Total bone and soft tissue volume loss (in cubic centimeters). Bone collapse measured in mm from the most buccal point to most palatal point of the ridge.
Measured: 1Year
Ridge dimensions (Bone and soft tissue from buccal to palatal) Changes from Implant placement in alveolar extraction sockets (Day 1) to 2 month after osseointegration (Day 3), in Zirconia Immediate Implants
Physiologic resorption rate from Day 1 - implant placement to Day 3- 3 month after final crown insertion measured by STL superimposition. Acquisition of STL File with an IOS in both time frames, and in an STL reader software (Geomagic Control X) we merge them with the corresponding common landmarks for a best fit alignment.
Measure include, Total bone and soft tissue volume loss (in cubic centimeters). Bone collapse measured in mm from the most buccal point to most palatal point of the ridge.
Measured: 1year
Secondary outcomes (2)
Survival Rate of Zirconia Immediate implants
Evaluate osseoitegration and the long term behavior of immediacy with zirconia implants
Measured: 5 years
Rate of complications
Track a log book on complications when using immediate zirconia implants
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start26 Jan 2019
- Primary completion26 Jul 2020 (estimated)
- Study completion26 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImplantStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Chen, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027660
- Sponsor's protocol ID
- II-10
- Status last verified
- Apr 2020
- First submitted
- 12 Jul 2019
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric (Hard and Soft Tissue) Alterations in Immediate Zirconia Implants
- ClinicalTrials.gov ID
- NCT04027660
- Acronym / sponsor ID
- II-10
- Conditions
- Implant
- Keywords
- dentistry, zirconia, implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- 26 Jan 2019 (actual)
- Primary completion
- 26 Jul 2020 (estimated)
- Study completion
- 26 Aug 2020 (estimated)
- First posted
- 22 Jul 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.
The aim is to study bone and soft tissue response to zirconia immediate implants.Volumetric changes will be measured before tooth extraction and after final crow placement.
Detailed description
Bone remodeling around immediate implants is a reality in clinical and literature arena. much is known about titanium implants but little in zirconia implants
In patients that require a tooth extraction anywhere in the oral cavity except 3rd molars are candidates fo the study. Once clinical conditions are establish and medical clearance is ok, the decision for an immediate implant is taken.
Patient will undergo for an intraoral Scanner (IOS, Trios 3Shape) to get an STL file of the previous situation.
On the day of surgery an atraumatically tooth extraction is performed (without rasing a flap) and a Zirconia implant is inserted on the alveolar socket.
The jumping gap (distance from crystal bone to implant body will be filled with a zenograft type of biomaterial) no sutures or membrane will be used.
A provisional crown or an individualized healing abutment will be placed. After 3 month healing an IOS will be made for crown fabrication and a second STL file generated.
After 15 days final crown will be placed, and 3 month after a 3rd IOS made to get the 3rd and final STL file.
An STL software will then make the correlation between the volume behavior in those 3 stages.
The control group, patients go for tooth extraction but no immediate implant and undergo with a classic protocol for implant placement. In this case the STL files are taken pre-operatory, before implant placement 3 month after tooth extraction, 2 month after implant placement (at final impression level), and 3 month after crown placement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Immediate Zirconia Implants | – | Device: Immediate Zirconia Dental ImplantGroup Formation : patients that require a tooth extraction and have the following clinical indications to be enrolled in an immediate implant. 1. No Active Infection 2. No loss of buccal plate 3. ASA 1 or ASA 2 Patient Extraction of the tooth will be performed and in the same clinical act, a zirconia dental implant will be placed toghether with a provisional or an individualized customs healing abutment. The jumping gap will be filled with a xenograft biomaterial. Final Zirconia Crown delivered 3 month after healing. 3 STL files will be generated - Before extraction, at Final impression level 3 month after implant placement, at 3 month after final prosthesis insertion Measure 1,2 and 3 will be at the gingival margin(measure 1), at 2mm (measure 2) and 4 mm (measure 3) apical to gingival margin. Both palatal and buccal references are joined by a line that gives a distance.Difference on the dimensions of each line with different time of evaluation represent ridge loss. |
| Non-exposed delayed Zirconia implants | – | –Group Formation : patients that require a tooth extraction and have the following clinical indications not to be enrolled in an immediate implant. 1. Active Infection 2. Loss of the buccal plate. Extraction will be performed but a classical implant approach will be made, that include a waiting period of 3 month before implant placement and 3 month after osseointegration period before place final crown. Implant placement with Guided bone regeneration (xenograft), if needed. Final Zirconia Crown 3 month after implant placement. 4 STL files will be generated - Before extraction, before implant placement, at Final impression level 3 month after implant placement, at 3 month after final prosthesis insertion Measure 1,2 and 3 the same has the other group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sequential recruiting, middle age, moderate to high income
Key inclusion criteria (7 listed)
- Patients with a non-restorable tooth schedule for extraction
- Anywhere on the mouth except 3rd molar teeth
- Tooth site with no active infection
- No loss of the buccal, palatal or inter proximal bone
- If chronical apical pathology, the six should be less that 4 mm diameter
Key exclusion criteria (7 listed)
- Site has an active infection
- Periapical lesion Beyond 5 mm
- Bone resorption of buccal, palatal or inter proximal plate beyond 2 mm
- Patient doesn't want an immediate implant
- Patient doesn't want a Zirconia Implant
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 |
|---|---|---|
| Immediate Zirconia Dental ImplantFor the Exposed Group the Intervention will be the following The Surgical procedure will envolve : 1. Administration of Articain 1:200.000 2. No flap procedure 3. Place a Zirconia Implant on the alveolar post extraction socket 4. Place xenograft biomaterial in the jumping gap 5. Place a provisional crown/individualized healing abutment The Prosthodontic procedure will evolve: * Final Impression with a IOS * Placement of the Final Crown * 3 month post crown post op 3 IOS will be made for volumetric evaluation : 1. before tooth extraction 2. 3 month of Osseointegration for final impression 3. 3 month after final crown is placed Final STL evaluation will be performed on a specialized software for volumetric measurements | Device | Exposed Immediate Zirconia Implants |
Primary outcome
Ridge dimensions (Bone and soft tissue from buccal to palatal) Changes from Implant placement in alveolar extraction sockets (Day 1) to final impression, 2 month after osseointegration (Day 2), in Zirconia Immediate Implants
Time frame: 1 year
Physiologic resorption rate (measured in a buccal to palatal dimension) from day 1 - Immediate implant in an alveolar extraction socket to Day 2 - Day of final Impression measured by STL superimposition. Acquisition of STL File with an IOS in both time frames, and in a STL reader software (Geomagic Control X) we merge them with the corresponding common landmarks for a best fit alignment. Measure include, Total bone and soft tissue volume loss (in cubic centimeters). Bone collapse measured in mm from the most buccal point to most palatal point of the ridge.
Ridge dimensions (Bone and soft tissue from buccal to palatal) Changes from final impression (Day 2 ) to 2 month after osseointegration (Day 3), in Zirconia Immediate Implants
Time frame: 1Year
Physiologic resorption rate from Day 2 - Day of final Impression to Day 3- 3 month after final crown insertion measured by STL superimposition. Acquisition of STL File with an IOS in both time frames, and in an STL reader software (Geomagic Control X) we merge them with the corresponding common landmarks for a best fit alignment. Measure include, Total bone and soft tissue volume loss (in cubic centimeters). Bone collapse measured in mm from the most buccal point to most palatal point of the ridge.
Ridge dimensions (Bone and soft tissue from buccal to palatal) Changes from Implant placement in alveolar extraction sockets (Day 1) to 2 month after osseointegration (Day 3), in Zirconia Immediate Implants
Time frame: 1year
Physiologic resorption rate from Day 1 - implant placement to Day 3- 3 month after final crown insertion measured by STL superimposition. Acquisition of STL File with an IOS in both time frames, and in an STL reader software (Geomagic Control X) we merge them with the corresponding common landmarks for a best fit alignment. Measure include, Total bone and soft tissue volume loss (in cubic centimeters). Bone collapse measured in mm from the most buccal point to most palatal point of the ridge.
2 secondary outcomes
Survival Rate of Zirconia Immediate implants
Time frame: 5 years
Rate of complications
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- 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?
An observational study of Implant, run by Implantology Institute at 1 site in Portugal.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Apr 2020. 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 Portugal. 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?
Results are not available in the source record.
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?
Ridge dimensions (Bone and soft tissue from buccal to palatal) Changes from Implant placement in alveolar extraction sockets (Day 1) to final impression, 2 month after osseointegration (Day 2), in Zirconia Immediate Implants (time frame: 1 year). The study lists 3 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 21 Apr 2020.