Outcome of Immediate Zirconia Implants

NCT04027660 | Unknown

• 1 other identifier: II-10
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Implant

Keywords

dentistry; zirconia; implants

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Survival Rate of Zirconia Immediate implants

  5 years

• Rate of complications

  1 Year

Study Arms (2)

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.

Device: Immediate Zirconia Dental Implant

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

Interventions

Immediate Zirconia Dental Implant DEVICE

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

Exposed Immediate Zirconia Implants

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sequential recruiting, middle age, moderate to high income

You may qualify if:

• 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 -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Implantology Institute: lead

Study Sites (1)

Instituto de Implantologia

Lisbon, 1500-662, Portugal

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 22, 2019
• Study Start: January 26, 2019
• Primary Completion: July 26, 2020
• Study Completion: August 26, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)