Implant Supported Single Crowns With Different Retention Modes

NCT04707716 | Completed

• 1 other identifier: 32-578 ex 19/20
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complications: Inflammatory Reactions, Mechanical Complications

Keywords

MMP-8; marginal bone level; conometric concept - Acuris; crown retention; all-ceramic crown

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (12)

• Change of probing depth (PD)

  at baseline, 4, 7, 10, 16 months after implantation

• Number of occurrences of chipping

  measured after integration of implant crown 3, 6 and 12 months after restoration

• soft tissue maintenance

  measured 4 months after implant placement and 3, 6 and 12 months after restoration

• technician satisfaction

  measured 12 months after restoration

• dentist satisfaction

  measured 12 months after restoration

Study Arms (3)

conometric concept (Acuris system)

EXPERIMENTAL

single implant crown retention using friction only

Other: conometric concept Acuris system

screw retention

ACTIVE COMPARATOR

screw retained implant Crown fixation

Other: screw retention

cementation

ACTIVE COMPARATOR

cement retained implant Crown fixation

Other: cementation

Interventions

conometric concept Acuris system OTHER

implant crown retention type using friction only

conometric concept (Acuris system)

screw retention OTHER

screw retained implant crown

screw retention

cementation OTHER

cement retained implant crown

cementation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• capability of giving an informed consent

You may not qualify if:

• age 18 to 99 years
• Good periodontal status: BOP \< 20%, PI \< 30%, no PD \> 4mm
• No heavy smokers (\< 10 cigarettes/day)
• at least 1 missing tooth in the premolar and molar region (with at least a mesial neighboring tooth/implant showing adequate hard- and soft tissue situation without the need of crestal hard- or soft tissue augmentation) either in the maxilla or in the mandible requiring implant therapy for reconstruction, requiring sinus floor augmentation or not.
• Insufficient bone volume for implant placement requiring GBR (guided bone regeneration) procedure in crestal area.
• Heavy Smokers (\>10 cigarettes/day)
• Medication with a contraindication for implant therapy (especially antiresorptive therapy, ongoing or recently completed local radiotherapy, systematic diseases, ongoing immunosuppressive therapy, functional disorders like Bruxism).
• Skeletal immaturity.
• Any active malignancy or ongoing treatment for malignancy.
• An active infection (e.g. caries, gingivitis, periodontitis) at or in the neighboring area of the operative site.
• Pregnancy
• unable or unwilling to return for follow-up visits for a period of at least 16 months

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz, Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics

Graz, 8010, Austria

Location

Related Publications (15)

• 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.

  PMID: 9842506 BACKGROUND

• Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.

  PMID: 9497723 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.

  PMID: 30861635 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.

  PMID: 3083006 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.

  PMID: 26589441 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.

  PMID: 11203567 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.

  PMID: 11145357 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.

  PMID: 24396843 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.

  PMID: 27153291 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.

  PMID: 23062142 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.

  PMID: 16938801 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.

  PMID: 19627514 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.

  PMID: 16968383 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.

  PMID: 30328283 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.

  PMID: 24224895 BACKGROUND

MeSH Terms

Interventions

Cementation

Intervention Hierarchy (Ancestors)

Investigative Techniques; Dental Bonding; Dentistry

Study Officials

• Norbert Jakse, UnivProfDDr

  Department of Dental Medicine and Oral Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 13, 2021
• Study Start: March 4, 2021
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

AU (1)