Dental ImplantsNCT06647381
Implant-related Outcomes in the Context of Maxillary Sinus Lifting
An observational study of Dental Implants, run by University of Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jun 2026to 30 Jul 2026
- How long will I take part?
- 25 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implant-related Outcomes in the Context of Maxillary Sinus Lifting: A Prospective Study With 25 Years Follow-up
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
Read more
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.
Read the detailed description
Patients included in the previous case series study who received tooth replacement therapy with dental implants and maxillary sinus augmentation procedures will be invited for a recall exam at the Department of Oral Surgery to be part of this prospective case series study. During this recall exam, photographs, a comprehensive anamnesis, followed by a standard clinical and digital examination, as well as patient-reported outcomes will be performed.
Primary and secondary outcomes will be measured and collected, and it will be tested whether long-term MBL is smaller than the clinically relevant 5mm limit. As there is no reference group available and previously published raw data was presumably deleted due to data protection reasons, measurements of secondary outcomes will be summarized by calculating means (continuous data) or percentages (categorical data) including 95% confidence intervals, and compared to reported data from standard implant placement in other publications.
The reason for selecting this criterion is due to the new criteria published in the new classification of periodontal and peri-implant diseases and conditions, where a diagnosis of peri-implantitis should have 3mm of marginal bone levels respecting the implant's platform (Schwarz 2018).
To the best of the investigators' knowledge, this observational single-center study will be the first study providing the effectiveness of implant therapy in addition to sinus floor elevation procedures with a follow-up longer than 20 years. The findings of this study could bring a valuable perspective on the replacement of missing teeth with dental implants and could provide clinicians and researchers all over the world with reasons that guide the clinical decision-making process.
- Conditions
- Dental Implants
- Keywords
- Dental Implants, Sinus lift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sinus lifting | Patients from a previous cohort of patients that received dental implants with sinus augmentation procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 25 years
Secondary outcomes (6)
Demographics
Age (years), sex, ethnicity, systemic factors, habits, oral hygiene techniques, frequency (times/day), and supportive periodontal/implant therapy (times/year).
Measured: 25 years
Clinical parameters
Probing depth (mm), presence of bleeding on probing and suppuration on probing, gingival/mucosal recession (mm), keratinized tissue width (mm), mobility, mucosal thickness (mm), presence of local contributing factors (i.e., presence of aberrant frenum attachment).
Measured: 25 years
Radiographic parameters
Marginal bone levels (mm), presence of periapical pathosis, distance from the adjacent teeth/implants (mm), presence of open contacts, efficacy of sinus augmentation procedure.
Measured: 25 years
Implant-related
Length and dimension of the dental implant (mm), manufacturer, the timing of implant placement after extraction, needed for additional bone or soft tissue augmentation procedures.
Measured: 25 years
Prosthetic-related
Analysis of occlusion (Dental-PreScale), integrity of prosthetic restoration (survival and success rates), technical complications, esthetic score (Pink and White Esthetic Scores), occlusal contacts.
Measured: 25 years
Patient-reported Outcome Measures
Visual Analog Score for the use of Oral Health Impact Profile-14, Visual Analog Score for the satisfaction of the treatment, etc
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start15 Jun 2026
- Primary completion30 Jul 2026
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilio Couso-Queiruga, DDS, MS, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647381
- Sponsor's protocol ID
- 2024-01280
- Status last verified
- Feb 2026
- First submitted
- 3 Oct 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be provided in a further publication based on the cohort of patients and not by single individuals.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant-related Outcomes in the Context of Maxillary Sinus Lifting: A Prospective Study With 25 Years Follow-up
- ClinicalTrials.gov ID
- NCT06647381
- Acronym / sponsor ID
- 2024-01280
- Conditions
- Dental Implants
- Keywords
- Dental Implants, Sinus lift
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients included in the previous case series study who received tooth replacement therapy with dental implants and maxillary sinus augmentation procedures will be invited for a recall exam at the Department of Oral Surgery to be part of this prospective case series study. During this recall exam, photographs, a comprehensive anamnesis, followed by a standard clinical and digital examination, as well as patient-reported outcomes will be performed.
Primary and secondary outcomes will be measured and collected, and it will be tested whether long-term MBL is smaller than the clinically relevant 5mm limit. As there is no reference group available and previously published raw data was presumably deleted due to data protection reasons, measurements of secondary outcomes will be summarized by calculating means (continuous data) or percentages (categorical data) including 95% confidence intervals, and compared to reported data from standard implant placement in other publications.
The reason for selecting this criterion is due to the new criteria published in the new classification of periodontal and peri-implant diseases and conditions, where a diagnosis of peri-implantitis should have 3mm of marginal bone levels respecting the implant's platform (Schwarz 2018).
To the best of the investigators' knowledge, this observational single-center study will be the first study providing the effectiveness of implant therapy in addition to sinus floor elevation procedures with a follow-up longer than 20 years. The findings of this study could bring a valuable perspective on the replacement of missing teeth with dental implants and could provide clinicians and researchers all over the world with reasons that guide the clinical decision-making process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 25 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinus lifting | – | –Patients from a previous cohort of patients that received dental implants with sinus augmentation procedures |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 25 years
Utilizing periapical radiographs
6 secondary outcomes
Demographics
Time frame: 25 years
Clinical parameters
Time frame: 25 years
Radiographic parameters
Time frame: 25 years
Implant-related
Time frame: 25 years
Prosthetic-related
Time frame: 25 years
Patient-reported Outcome Measures
Time frame: 25 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. Data will be provided in a further publication based on the cohort of patients and not by single individuals.
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The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilio Couso-Queiruga, DDS, MS study chair
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 25 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.