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40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group).
Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used.
Allogenic bone botiss maxgraft® cortical granules are used as graft material.
Inclusion criteria:
Exclusion criteria:
General Notes
40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group).
Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used.
Allogenic bone botiss maxgraft® cortical granules are used as graft material.
Inclusion criteria:
Exclusion criteria:
Group 1. Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone.
After 3 months, a cone beam computed tomography is performed to evaluate changes in the crestal bone, the temporary restoration is screwed off and the presence/absence of bleeding is recorded. A digital impression is taken for a zirconium oxide crown made on Ti base and to assess soft tissue changes.
The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest.
While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later.
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability. Measurements will be taken before, immediately after the surgery and 3 month later. By using STL files it will be possible to compare soft tissue stability.
Group 2. Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone.
After 3 months, a cone beam computed tomography is performed to evaluate changes in the crestal bone, the custom-made abutment is screwed off and the presence/absence of bleeding is recorded. A digital impression is taken for a zirconium oxide crown and to assess soft tissue changes.
The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest.
While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later.
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability. Measurements will be taken before, immediately after the surgery and 3 month later. By using STL files it will be possible to compare soft tissue stability.
Evaluation Phase
T1 (Basic): After the performance of final restoration: X-ray, photograph, scan, PD, BOP, RI.
T2: Follow-up after 3 months: X-ray, photograph, scan, PD, BOP, RI. T3: Follow-up after a year: X-ray, photograph, scan, PD, BOP, RI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kompozite closure | Other | Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone. |
|
| Individual abutment | Other | Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kompozite closure | Procedure | Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stability of crestal bone | To compare crystal bone stability CBCT will be taken before surgery. , immediately after surgery, after 3 month and a follow up after 1 year. The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest. While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later | Before surgery, immediately after surgery, 3 moth, 1 year follow up |
| The changes of stability of soft tissue | Recession (REC) state of the gingival/mucosa border - registered by means of a periodontal probe from the incisal edge to the border of the medial, zenith and distal zones. There are taken scans with 3Shape Trios4 before surgery, immediately after, then 3 month and 1 year follow up to compare soft tissue stability | Before surgery, immediately after surgery, 3 month, 1 year follow up |
| The change of position of implant using surgical guide | To compare implant position accuracy using surgical guide, the following two things will be compared: DICOM after the surgery witch contains information on the implant position in the bone and the STL file witch contains information on implant position before the surgery. There are taken cone beam computer tomography before and immediately after surgery, then 3 month and 1 year follow up. | Before surgery and immediately after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ģirts Šalms, Asoc.prof | Riga Stradiņš University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adenta | Riga | Latvija | LV-1045 | Latvia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33438320 | Result | Alexopoulou M, Lambert F, Knafo B, Popelut A, Vandenberghe B, Finelle G. Immediate implant in the posterior region combined with alveolar ridge preservation and sealing socket abutment: A retrospective 3D radiographic analysis. Clin Implant Dent Relat Res. 2021 Feb;23(1):61-72. doi: 10.1111/cid.12974. Epub 2021 Jan 13. | |
| 30246362 | Result |
| Label | URL |
|---|---|
| Customized sealing socket abutment (SSA) has been claimed to optimize the peri-implant hard and soft tissues in type 1 implant placement. | View source |
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Each patient has their individual ID number
| Individual abutment | Procedure | Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment. |
|
| Sanz-Martin I, Permuy M, Vignoletti F, Nunez J, Munoz F, Sanz M. A novel methodological approach using superimposed Micro-CT and STL images to analyze hard and soft tissue volume in immediate and delayed implants with different cervical designs. Clin Oral Implants Res. 2018 Oct;29(10):986-995. doi: 10.1111/clr.13365. Epub 2018 Sep 23. |
| 26194771 | Result | Guidetti LG, Monnazzi MS, Piveta AC, Gabrielli MA, Gabrielli MF, Pereira Filho VA. Evaluation of single implants placed in the posterior mandibular area under immediate loading: a prospective study. Int J Oral Maxillofac Surg. 2015 Nov;44(11):1411-5. doi: 10.1016/j.ijom.2015.06.021. Epub 2015 Jul 18. |
| 40692347 | Derived | Gnusins V, Akhondi S, Zvirblis T, Pala K, Gallucci GO, Puisys A. Chairside vs Prefabricated Sealing Socket Abutments for Posterior Immediate Implants: A Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Aug;27(4):e70076. doi: 10.1111/cid.70076. |
| To study the hard and soft tissue volume after placing immediate (IMI) or delayed implants (DLI) with a triangular coronal macro-design (Test/T) or a conventional cylindrical design (Control/C). | View source |
| The aim of this study was to evaluate the survival of single dental implants subjected to immediate function. Twelve patients with edentulous areas in the posterior mandible were included in the study. | View source |