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Implant-related Outcomes in the Context of Maxillary Sinus Lifting

NCT06647381 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-05-07

No results posted yet for this study

Summary

The population of interest will be recruited out of a cohort of patients who were initially treated at the Department of Oral Surgery and Stomatology between 1997 and 2001. The findings from a total of 56 patients that received tooth replacement treatment with dental implants during this period, were previously published in 2008. Now, 20 years later, the investigators will potentially recruit and re-examine as many patients as possible out of this original cohort. Exclusion criteria will be patients not able to come to the re-examination, concomitant diseases that compromise the health of this subject during the comprehensive examination (i.e., active severe infectious diseases, liver or kidney dysfunction/failure, currently under treatment), pregnant women, or unwilling to sign the consent form. Besides them, no further exclusion criteria are defined as patients receiving no intervention. The investigators assume that will be able to retrieve 40 patients having roughly 80 implants with sinus floor augmentation.

Recruitment, screening, and informed consent procedure

Patients treated at the Department of Oral Surgery between 1997 and 2001 and who were included in the previous case series study will be potentially recruited. Patients who are willing to participate will receive informed consent. The risks and benefits of being part of this study will be thoroughly explained to the patients without a limit of time. All the questions will be answered. After signing the informed consent patients will be examined. The participants will not be charged any costs for the recall examination.

Study procedures

After ethical approval, available patients will be screened and recruited for a re-examination visit. The anamnesis of the patients will be assessed using a questionnaire. In case of uncertainties regarding the medical history, a report from the patient's physician will be requested. During this re-examination, photographs, in combination with a comprehensive and standard clinical and digital examination will be taken. Further, patients will be given questionnaires to assess patient-reported outcomes. The evaluation visit will take place within a maximum of 1 hour, as the normal time required for a recall appointment on this type of patient with the presence of dental implants. Besides this one re-examination, no more visits will be necessary for the study outcomes. Data will be encrypted and collected in Redcap Software. The key for the encryption will be set up and stored by a person who is not involved in the study.

Conditions

  • Dental Implants

Sponsors & Collaborators

  • University of Bern

    lead OTHER

Principal Investigators

  • Emilio Couso-Queiruga, DDS, MS · University of Bern

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06647381 on ClinicalTrials.gov