Outcome of Immediate Zirconia Implants

Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04027660
• Other study ID #: II-10
• Status: Active, not recruiting
• Start date: January 26, 2019
• Est. completion date: August 26, 2020

Study information

• Verified date: April 2020
• Source: Instituto de Implantologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: August 26, 2020
• Est. primary completion date: July 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Implant

Intervention

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 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

Locations

Country	Name	City	State
Portugal	Instituto de Implantologia	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Implantologia

Country where clinical trial is conducted

Portugal, 

Outcome

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