Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
10 participants
OBSERVATIONAL
2019-01-26
2020-08-26
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Immediate Zirconia Dental Implant
For 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
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
No interventions assigned to this group
Interventions
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Immediate Zirconia Dental Implant
For 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
Eligibility Criteria
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Inclusion Criteria
2. Anywhere on the mouth except 3rd molar teeth
3. Tooth site with no active infection
4. No loss of the buccal, palatal or inter proximal bone
5. If chronical apical pathology, the six should be less that 4 mm diameter
6. ASA 1 or ASA 2 Patient
7. Sings the Informed consent -
Exclusion Criteria
2. Periapical lesion Beyond 5 mm
3. Bone resorption of buccal, palatal or inter proximal plate beyond 2 mm
4. Patient doesn't want an immediate implant
5. Patient doesn't want a Zirconia Implant
6. ASA 3 or ASA 4 Patient
7. Refuse to Sign informed consent -
20 Years
ALL
Yes
Sponsors
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Implantology Institute
OTHER
Responsible Party
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Andre Chen
Assistant Professor
Locations
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Instituto de Implantologia
Lisbon, , Portugal
Countries
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Other Identifiers
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II-10
Identifier Type: -
Identifier Source: org_study_id
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