CompletedNot Applicable

Short Implants Supporting Single Crowns in the Posterior Region

Brazil20 participantsStarted 2021-09-20

Plain-language summary

The aim of the present project is to evaluate functional, biological and technical variables, as well as quality of life and satisfaction as indicators of long-term clinical performance of single prostheses on short implants in the posterior region with a 10-year prospective follow-up. This proposal refers to a clinical research project with a 10-year follow-up of single crowns on short implants (6 mm) in the posterior region of the maxilla and mandible. The cohort has started in 2010 through a project funded by the International Team for Implantology. The main clinical results with a 4-year follow-up showed the influence of biomechanical factors (implant/crown ratio) on short-term treatment success and increased risk over time. The sample will consist of participants from the cohort of the research project established in 2010, who received a single crown on a short implant (6-mm Standard Plus Wide Neck SLA) in the posterior region of the maxilla or mandible according to eligibility criteria and standardized clinical procedures. Data will be collected by clinical and image exams, questionnaires (for sleep bruxism, satisfaction and quality of life), recording of maximum occlusal force, measurement of perimplant bone changes, and calculation of the clinical crown-implant ratio. Data will be analyzed by descriptive and inferential statistics with survival analysis and multivariable models, if assumptions are met, at the significance level of 0.05.

Who can participate

Age range

30 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.

The study sample will consist of participants from the 2010-cohort, who were selected according to the following eligibility criteria: Inclusion Criteria: * need for single implants in the posterior region of the maxilla and mandible; * indication of 6-mm implants according to preoperative evaluation Exclusion Criteria: * previous problems with osseointegration failure in the region of interest; * bone graft or use of biomaterials; * diabetes; * heavy tobacco use (over 10 cigarettes per day); * immunosuppression; * local radiation therapy; * poor oral hygiene; * active periodontal disease in the remaining teeth; * cystic or neoplastic lesions; * removable dentures in the opposing arch.

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

Ten-year Implant survival

Timeframe: 10-year follow-up

Ten-year prosthesis survival

Timeframe: 10-year follow-up

Trial details

NCT IDNCT05081050

SponsorPontificia Universidade Católica do Rio Grande do Sul

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-07-31

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