Implant-related Outcomes in the Context of Maxillary Sinus Lifting

NCT06647381 | Enrolling By Invitation DMC

• 1 other identifier: 2024-01280
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dental Implants; Sinus lift

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is to assess the marginal bone loss (MBL) on the radiographs of implant-supported fixed partial dentures in patients who received maxillary sinus floor augmentation procedures.

  Utilizing periapical radiographs

  25 years

Secondary Outcomes (6)

• Demographics

  25 years

• Clinical parameters

  25 years

• Radiographic parameters

  25 years

• Implant-related

  25 years

• Prosthetic-related

  25 years

Study Arms (1)

Sinus lifting

Patients from a previous cohort of patients that received dental implants with sinus augmentation procedures

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Patients who were initially treated at the Department of Oral Surgery and Stomatology between 1997 and 2001
• Implant placement in the presence of a sinus floor augmentation procedure received during this period
• Patients involved in a previous cohort study

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

School of Dental Medicine

Bern, 3012, Switzerland

Location

Study Officials

• Emilio Couso-Queiruga, DDS, MS

  University of Bern

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 17, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)