Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647381
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Implant-related Outcomes in the Context of Maxillary Sinus Lifting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implant-related Outcomes in the Context of Maxillary Sinus Lifting A Prospective Study With 25 Years Follow-up
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie active severe infectious diseases liver or kidney dysfunctionfailure 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 patients 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
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 patients 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 implants 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
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 implants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None