Implant Supported Single Crowns With Different Retention Modes

NCT ID: NCT04707716

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-04

Study Completion Date

2025-11-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complications: Inflammatory Reactions, Mechanical Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

conometric concept (Acuris system)

single implant crown retention using friction only

Group Type EXPERIMENTAL

conometric concept Acuris system

Intervention Type OTHER

implant crown retention type using friction only

screw retention

screw retained implant Crown fixation

Group Type ACTIVE_COMPARATOR

screw retention

Intervention Type OTHER

screw retained implant crown

cementation

cement retained implant Crown fixation

Group Type ACTIVE_COMPARATOR

cementation

Intervention Type OTHER

cement retained implant crown

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

conometric concept Acuris system

implant crown retention type using friction only

Intervention Type OTHER

screw retention

screw retained implant crown

Intervention Type OTHER

cementation

cement retained implant crown

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* capability of giving an informed consent

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Norbert Jakse, UnivProfDDr

Role: PRINCIPAL_INVESTIGATOR

Department of Dental Medicine and Oral Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Graz, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 9842506 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 9497723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30861635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3083006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26589441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11203567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11145357 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24396843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27153291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23062142 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16938801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19627514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16968383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30328283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24224895 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

32-578 ex 19/20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.