Outcome of Immediate Zirconia Implants

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.

Study Overview

• Status: Unknown
• Conditions: Implant
• Intervention / Treatment: Device: Immediate Zirconia Dental Implant

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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal, 1500-662
    • Instituto de Implantologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Sequential recruiting, middle age, moderate to high income

Description

Inclusion Criteria:

1. Patients with a non-restorable tooth schedule for extraction
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:

1. Site has an active infection
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 -

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; No Active Infection; No loss of buccal plate; 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.	Device: Immediate Zirconia Dental Implant; 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 op3 IOS will be made for volumetric evaluation :before tooth extraction3 month of Osseointegration for final impression3 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.; Active Infection; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Rate of Zirconia Immediate implants	Evaluate osseoitegration and the long term behavior of immediacy with zirconia implants	5 years
Rate of complications	Track a log book on complications when using immediate zirconia implants	1 Year

Collaborators and Investigators

• Sponsor: Implantology Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2019
• Primary Completion (Anticipated): July 26, 2020
• Study Completion (Anticipated): August 26, 2020

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: dentistry; implants; zirconia
• Other Study ID Numbers: II-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No