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Completed

NCT Number: NCT04707716

Implant Supported Single Crowns With Different Retention Modes

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Graz, 8010, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Pregnancy
  • unable or unwilling to return for follow-up visits for a period of at least 16 months

Treatment and study plan

conometric concept Acuris system

Other

implant crown retention type using friction only

screw retention

Other

screw retained implant crown

cementation

Other

cement retained implant crown

Primary outcomes

  1. Change of marginal bone level

    Time frame: at baseline, 4 months after implant placement and 3, 6 and 12 months after restoration

    assessed by single tooth x-ray; in mm

  2. Change of matrix metalloproteinase 8 level

    Time frame: 4 months after implant placement, 3, 6 and 12 months after integration of the implant crown

    biomarker for Inflammation of peri-implant disease; in ng/ml

Secondary outcomes

  1. Change of probing depth (PD)

    Time frame: at baseline, 4, 7, 10, 16 months after implantation

    using a periodontal probe; in mm

  2. Number of occurrences of chipping

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

    visual check

  3. soft tissue maintenance

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

    Papilla Index (Jemt T, 1997), the index ranges from 0 to 4, while 2 and 3 indicate physiological outcome

  4. technician satisfaction

    Time frame: measured 12 months after restoration

    evaluated using an individual questionnaire

  5. dentist satisfaction

    Time frame: measured 12 months after restoration

    evaluated using an individual questionnaire

  6. patient satisfaction

    Time frame: measured at baseline, 3 and 12 months after restoration

    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).

  7. Plaque Index (PI)

    Time frame: at baseline, 4, 7, 10 and 16 months after implantation

    in percent

  8. Bleeding on Probing (BOP)

    Time frame: at baseline, 4, 7, 10 and 16 months after implantation

    in percent

  9. Patient satisfaction concerning the implant crown

    Time frame: measured 12 months after restoration

    evaluated using an individual questionnaire

  10. Number of occurrences of fractures

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

    visual check

  11. Number of occurrences of screw loosening

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

    visual check

  12. Number of occurrences of crown loosening

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

    visual check

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2021
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.