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This study aims to examine the inflammatory response mediated by MMP-8 (Matrix metalloproteinase-8 ) level in peri-implant sulcus fluid adjacent to screw-retained, cemented or using the Acuris-system fixed single implant crowns as well as changing of the marginal bone level within the first year after implant restoration. Furthermore periodontal parameters, patient satisfaction and possible occurring biological or technical complications will be evaluated.
After giving their written consent volunteers will be screened and eligible subjects will be randomized to three different groups. In group 1 Acuris® is used as fixation type; in group 2 screw retention, and in group 3 cementation is used. After 3 months of submerged healing the dental implants will be restored with all ceramic single implant crowns, fixed by using the randomized fixation mode. Follow-up visits till one year after implant restoration will be performed. At least 11 study visits during 16 months will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conometric concept (Acuris system) | Experimental | single implant crown retention using friction only |
|
| screw retention | Active Comparator | screw retained implant Crown fixation |
|
| cementation | Active Comparator | cement retained implant Crown fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conometric concept Acuris system | Other | implant crown retention type using friction only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of marginal bone level | assessed by single tooth x-ray; in mm | at baseline, 4 months after implant placement and 3, 6 and 12 months after restoration |
| Change of matrix metalloproteinase 8 level | biomarker for Inflammation of peri-implant disease; in ng/ml | 4 months after implant placement, 3, 6 and 12 months after integration of the implant crown |
| Measure | Description | Time Frame |
|---|---|---|
| Change of probing depth (PD) | using a periodontal probe; in mm | at baseline, 4, 7, 10, 16 months after implantation |
| Number of occurrences of chipping | visual check |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Jakse, UnivProfDDr | Department of Dental Medicine and Oral Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz, Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics | Graz | 8010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9842506 | Background | DeCarlo AA, Grenett HE, Harber GJ, Windsor LJ, Bodden MK, Birkedal-Hansen B, Birkedal-Hansen H. Induction of matrix metalloproteinases and a collagen-degrading phenotype in fibroblasts and epithelial cells by secreted Porphyromonas gingivalis proteinase. J Periodontal Res. 1998 Oct;33(7):408-20. doi: 10.1111/j.1600-0765.1998.tb02337.x. | |
| 9497723 |
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| ID | Term |
|---|---|
| D002484 | Cementation |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D001840 | Dental Bonding |
| D003813 | Dentistry |
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| screw retention | Other | screw retained implant crown |
|
| cementation | Other | cement retained implant crown |
|
| measured after integration of implant crown 3, 6 and 12 months after restoration |
| soft tissue maintenance | Papilla Index (Jemt T, 1997), the index ranges from 0 to 4, while 2 and 3 indicate physiological outcome | measured 4 months after implant placement and 3, 6 and 12 months after restoration |
| technician satisfaction | evaluated using an individual questionnaire | measured 12 months after restoration |
| dentist satisfaction | evaluated using an individual questionnaire | measured 12 months after restoration |
| patient satisfaction | evaluated using OHIP-G 14 questionnaire. The following dimensions are captured by the OHIP-G 14: functional Limitation (e.g., "pronouncing any words because of problems with your teeth, mouth, dentures, or jaw?") and physical Pain (e.g., "Have you had painful aching in your mouth"). 14 questions are raised, which are answered using a rating scale from 0 (never) to 4 (very often). | measured at baseline, 3 and 12 months after restoration |
| Plaque Index (PI) | in percent | at baseline, 4, 7, 10 and 16 months after implantation |
| Bleeding on Probing (BOP) | in percent | at baseline, 4, 7, 10 and 16 months after implantation |
| Patient satisfaction concerning the implant crown | evaluated using an individual questionnaire | measured 12 months after restoration |
| Number of occurrences of fractures | visual check | measured after integration of implant crown 3, 6 and 12 months after restoration |
| Number of occurrences of screw loosening | visual check | measured after integration of implant crown 3, 6 and 12 months after restoration |
| Number of occurrences of crown loosening | visual check | measured after integration of implant crown 3, 6 and 12 months after restoration |
| Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33. |
| 30861635 | Background | Kraus RD, Epprecht A, Hammerle CHF, Sailer I, Thoma DS. Cemented vs screw-retained zirconia-based single implant reconstructions: A 3-year prospective randomized controlled clinical trial. Clin Implant Dent Relat Res. 2019 Aug;21(4):578-585. doi: 10.1111/cid.12735. Epub 2019 Mar 12. |
| 3083006 | Background | Lekholm U, Adell R, Lindhe J, Branemark PI, Eriksson B, Rockler B, Lindvall AM, Yoneyama T. Marginal tissue reactions at osseointegrated titanium fixtures. (II) A cross-sectional retrospective study. Int J Oral Maxillofac Surg. 1986 Feb;15(1):53-61. doi: 10.1016/s0300-9785(86)80011-4. |
| 26589441 | Background | Lemos CA, de Souza Batista VE, Almeida DA, Santiago Junior JF, Verri FR, Pellizzer EP. Evaluation of cement-retained versus screw-retained implant-supported restorations for marginal bone loss: A systematic review and meta-analysis. J Prosthet Dent. 2016 Apr;115(4):419-27. doi: 10.1016/j.prosdent.2015.08.026. Epub 2015 Nov 14. |
| 11203567 | Background | Lorenzoni M, Pertl C, Wegscheider W, Keil C, Penkner K, Polansky R, Bratschko RO. Retrospective analysis of Frialit-2 implants in the augmented sinus. Int J Periodontics Restorative Dent. 2000 Jun;20(3):255-67. |
| 11145357 | Background | Ma J, Kitti U, Teronen O, Sorsa T, Husa V, Laine P, Ronka H, Salo T, Lindqvist C, Konttinen YT. Collagenases in different categories of peri-implant vertical bone loss. J Dent Res. 2000 Nov;79(11):1870-3. doi: 10.1177/00220345000790110901. |
| 24396843 | Background | Meissen R, Mintcheva M, Netuschil L. Matrix metalloproteinase-8 levels in peri-implant sulcus fluid adjacent to titanium and zirconium nitride surfaces. Int J Periodontics Restorative Dent. 2014 Jan-Feb;34(1):91-5. doi: 10.11607/prd.1504. |
| 27153291 | Background | Penarrocha-Oltra D, Monreal-Bello A, Penarrocha-Diago M, Alonso-Perez-Barquero J, Botticelli D, Canullo L. Microbial Colonization of the Peri-Implant Sulcus and Implant Connection of Implants Restored With Cemented Versus Screw-Retained Superstructures: A Cross-Sectional Study. J Periodontol. 2016 Sep;87(9):1002-11. doi: 10.1902/jop.2016.160017. Epub 2016 May 6. |
| 23062142 | Background | Sailer I, Muhlemann S, Zwahlen M, Hammerle CH, Schneider D. Cemented and screw-retained implant reconstructions: a systematic review of the survival and complication rates. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:163-201. doi: 10.1111/j.1600-0501.2012.02538.x. |
| 16938801 | Background | Sorsa T, Tjaderhane L, Konttinen YT, Lauhio A, Salo T, Lee HM, Golub LM, Brown DL, Mantyla P. Matrix metalloproteinases: contribution to pathogenesis, diagnosis and treatment of periodontal inflammation. Ann Med. 2006;38(5):306-21. doi: 10.1080/07853890600800103. |
| 19627514 | Background | Sorsa T, Hernandez M, Leppilahti J, Munjal S, Netuschil L, Mantyla P. Detection of gingival crevicular fluid MMP-8 levels with different laboratory and chair-side methods. Oral Dis. 2010 Jan;16(1):39-45. doi: 10.1111/j.1601-0825.2009.01603.x. Epub 2009 Jul 8. |
| 16968383 | Background | Teughels W, Van Assche N, Sliepen I, Quirynen M. Effect of material characteristics and/or surface topography on biofilm development. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:68-81. doi: 10.1111/j.1600-0501.2006.01353.x. |
| 30328283 | Background | Thoma DS, Sailer I, Muhlemann S, Gil A, Jung RE, Hammerle CHF. Randomized controlled clinical study of veneered zirconia abutments for single implant crowns: Clinical, histological, and microbiological outcomes. Clin Implant Dent Relat Res. 2018 Dec;20(6):988-996. doi: 10.1111/cid.12674. Epub 2018 Oct 17. |
| 24224895 | Background | Vindasiute E, Puisys A, Maslova N, Linkeviciene L, Peciuliene V, Linkevicius T. Clinical Factors Influencing Removal of the Cement Excess in Implant-Supported Restorations. Clin Implant Dent Relat Res. 2015 Aug;17(4):771-8. doi: 10.1111/cid.12170. Epub 2013 Nov 14. |