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Clinical Trials/NCT04027660
NCT04027660
Unknown
Not Applicable

Volumetric (Hard and Soft Tissue) Alterations in Immediate Zirconia Implants

Implantology Institute1 site in 1 country10 target enrollmentJanuary 26, 2019
ConditionsImplant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Implant
Sponsor
Implantology Institute
Enrollment
10
Locations
1
Primary Endpoint
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
Last Updated
6 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
January 26, 2019
End Date
August 26, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Implantology Institute
Responsible Party
Principal Investigator
Principal Investigator

Andre Chen

Assistant Professor

Implantology Institute

Eligibility Criteria

Inclusion Criteria

  • 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 -

Exclusion Criteria

  • 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 -

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Rate of complications(1 Year)
  • Survival Rate of Zirconia Immediate implants(5 years)

Study Sites (1)

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