Implant Supported Single Crowns With Different Retention Modes - Effects on Peri-implant Tissue: A Prospective Randomized Controlled Clinical Trial

  • End date
    Nov 27, 2023
  • participants needed
  • sponsor
    Medical University of Graz
Updated on 27 October 2022
Accepts healthy volunteers


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.

Condition Complications: Inflammatory Reactions, Mechanical Complications
Treatment conometric concept Acuris system, screw retention, cementation, cementation
Clinical Study IdentifierNCT04707716
SponsorMedical University of Graz
Last Modified on27 October 2022


Yes No Not Sure

Inclusion Criteria

capability of giving an informed consent
good health as defined by the subjects medical history (no contraindications as described in the exclusion criteria below)
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

Exclusion Criteria

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
unable or unwilling to return for follow-up visits for a period of at least 16 months
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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