Outcome of Immediate Zirconia Implants

Implantology Institute

Status: Unknown

Conditions: Implant

Treatments: Device: Immediate Zirconia Dental Implant

Study type: Observational

Funder types: Other

Identifiers

NCT04027660

II-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

10 participants in 2 patient groups

Exposed Immediate Zirconia Implants

Description:

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.

Treatment:

Device: Immediate Zirconia Dental Implant

Non-exposed delayed Zirconia implants

Description:

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