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| Name | Class |
|---|---|
| Institut Straumann AG | INDUSTRY |
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The aims of our study are to investigate in patients with immediate implantation replacing a single tooth in the maxillary anterior (#FDI 15-25) region the effect of (a) custom vs cylindrical stock healing abutments, then (b) screw retained single ceramic crowns, on the peri implant hard- and soft-tissue formation and blood flow.
AIMS:
In the maxilla, in the aesthetic zone, in patients with a thick phenotype, for a crown anchored with a solo immediate implant:
I.A To investigate hard and soft tissue volume changes around custom CAD/CAM (computer-aided design and manufacturing) vs. cylindrical zirconiom-dioxide (ZrO2) healing abutments 4 months after their fixation for immediate implant placement.
I.B To measure the thickness of keratinized mucosa by ultrasound I.C Monitoring microcirculation in wound healing by laser speckle contrast imaging (LSCI) and ultrasound.
II. Custom zirconia abutment (on Ti-base) retained, screw-retained all-ceramic solo restorations:
ARMS:
A. immediate implantation + cylindrical healing abutment + CAD/CAM screw-retained (on Ti-base), full-countour monolithic zirconium-dioxide restoration
B. immediate implantation + custom healing abutment + CAD/CAM screw-retained (on Ti-base), custom ZrO2 abutment retained all-ceramic restoration with hand-built-up supramucosal veneering
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD/CAM custom ZrO2 healing abutment | Experimental | Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation. |
|
| Cylindrical ZrO2 healing abutment | Active Comparator | Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAD/CAM custom ZrO2 healing abutment | Device | Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| midfacial keratinized mucosa volume | Volume changes in midfacial mucosa [mm] | 4, 12, 36 months post op. |
| midfacial keratinized mucosa width | Keratinized mucosa width [mm] | 4, 12, 36 months post op. |
| Keratinized mucosa thickness | Keratinized mucosa thickness with ultrasound [mm] | before implantation, 4,12, 36 months post op. |
| Measure | Description | Time Frame |
|---|---|---|
| soft tissue volume | Follow-up of 2D linear and 3D volumetric changes in soft tissue using intraoral scanner | 4, 12, 36 months post op. |
| laser speckle contrast imaging (LSCI) | blood flow measurement with laser speckle contrast imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krisztina Mikulás, PhD | Contact | +36309365144 | mikulas.krisztina1@semmelweis.hu | |
| Péter Tajti | Contact | +3614591500 |
| Name | Affiliation | Role |
|---|---|---|
| Krisztina Mikulás, PhD | Semmelweis University, Department of Prosthodontics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University, Department of Prosthodontics | Recruiting | Budapest | Pest County | 1088 | Hungary |
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| Cylindrical ZrO2 healing abutment | Device | Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation. |
|
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| at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation |
| ultrasound | blood flow measurement with ultrasound | at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation |
| marginal bone loss | marginal bone loss | 4, 12, 36 months post op. |
| Implant survival | Number of survived implants out of total implants placed | 4, 12, 36 months |
| full mouth plaque score (FMPS) | % of sites with dental plaque over total measures sites | 0., 1., 7., 14. day, and 1., 2., 4., 6., 12., 36. month after implantation |
| full mouth bleeding score (FMBS) | % of sites with bleeding over total measures sites | 0. day, and 4., 12., 36. month after implantation |
| Probing depth (PPD) | Probing pocket depth | 0., 4., 12., 36. month after implantation |
| Functional implant prosthodontic score (FIPS) | Functional implant prosthodontic score | 4 months after implantation, at final restoration delivery |
| Pain at delivery | Pain numerical rating scale | 4 months after implantation, at final restoration delivery |