CompletedNot Applicable

Implant Supported Single Crowns With Different Retention Modes

Austria39 participantsStarted 2021-03-04

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of marginal bone level

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

Change of matrix metalloproteinase 8 level

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

Trial details

NCT IDNCT04707716

SponsorMedical University of Graz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-13

View on ClinicalTrials.gov More Complications: Inflammatory Reactions, Mechanical Complications trials