Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648564
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
20-25 Year Follow-Up on Regenerative Bone Procedures for Peri-Implantitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
20-25 Year Follow-Up After Surgical Treatment of Peri-Implantitis Using a Bone Substitute With or Without a Resorbable Membrane A Longitudinal Study
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:
periimpl20y
Brief Summary:
The goal of this 20-25-year observational study is to investigate the outcomes of bone regenerative surgery in peri-implantitis Two different techniques will be compared surgery with a bone substitute alone and surgery with a bone substitute combined with a membrane to determine their effectiveness and assess whether one is more effective than the other The intention of this observational study is to learn more about the long-term effects of bone regenerative surgery in patients with peri-implantitis
Patients will be called in for a clinical and radiographic examination of the surgically treated implants Probing pocket depths presence of pus bleeding around the implant s and a radiograph of the implant s
To be able to compare with the 1 3 5 and 10 year measurements
Patients will be called in for a clinical and radiographic examination of the surgically treated implants Probing pocket depths presence of pus bleeding around the implant s and a radiograph of the implant s
To be able to compare with the 1 3 5 and 10 year measurements
Detailed Description:
The aim of this 20-25 year observational follow-up study is to investigate the outcomes of bone regenerative surgery in peri-implantitis The study compares two approaches Group 1 surgery with a bone substitute alone Algipore and Group 2 surgery with a bone substitute Algipore combined with a membrane Osseoquest Both groups received systemic antibiotics-Amoxicillin 375 mg three times a day combined with Metronidazole 400 mg twice a day for 10 days starting the day before surgery
The objective of this observational study is to gain insights into the long-term effects of bone regenerative surgery in patients with peri-implantitis and to determine if there is a difference
The patients were enrolled in a strict maintenance program with supportive therapy every third months with a yearly evaluation
In this study patients will examined of the surgically treated implants after 20-25 years The examination will include a clinical assessment measuring probing pocket depths at each implant to the nearest millimeter using a standardized probing force of 025 N Hawe-Click Probe Kerr Hawe SA Bioggio Switzerland The prevalence of pus full-mouth bleeding on probing and bleeding grades will be recorded around the implants at four sites per tooth and implants as follows 0 no bleeding 1 point of bleeding 2 line of bleeding and 3 drop of bleeding The plaque index will be defined as either visible or not visible at the implant site using an erythrosine dye TopDent Lifco Dental AB Enköping Sweden All clinical assessments will be performed by the same periodontist AMRJ
Data from the clinical treatment were registered in patient records In parallel clinical data were documented in a study protocol and saved in a safe in accordance with standard operation procedure at the clinicThe protocol with medical records were not opened until the study was completed and only by authorized persons with access to the data in the study such as principal investigator and statisticians
In accordance with an international working group diagnosis of peri-implantitis should include pocket depth bleeding and bone loss X-ray Thus in this study the primary outcomes are radiographic evidence of bone fill and changes in probing depths at implants treated
Parametric tests independent t-tests equal variance not assumed and non-parametric tests Mann-Whitney U-test Wilcoxon test will be performed to assess differences over time and between groups Statistical significance will be declared at p lt005 The Kolmogorov- Smirnov test will be used to define if the data presented with normal distribution or not The SPSS PASW 290 statistical software SPSS Inc Chicago IL USA for Apple computer will be used in the analysis
Patients that will participate in the study will consecutively be given an ID code and data will be registered in the ordinary patient journal The code list will be placed in a locked up space at the clinic
All patients will be given oral and written information about the study and will sign a written informed consent The patients will be informed that they could drop off when ever they want without any explanations The ethical board approved the study
The objective of this observational study is to gain insights into the long-term effects of bone regenerative surgery in patients with peri-implantitis and to determine if there is a difference
The patients were enrolled in a strict maintenance program with supportive therapy every third months with a yearly evaluation
In this study patients will examined of the surgically treated implants after 20-25 years The examination will include a clinical assessment measuring probing pocket depths at each implant to the nearest millimeter using a standardized probing force of 025 N Hawe-Click Probe Kerr Hawe SA Bioggio Switzerland The prevalence of pus full-mouth bleeding on probing and bleeding grades will be recorded around the implants at four sites per tooth and implants as follows 0 no bleeding 1 point of bleeding 2 line of bleeding and 3 drop of bleeding The plaque index will be defined as either visible or not visible at the implant site using an erythrosine dye TopDent Lifco Dental AB Enköping Sweden All clinical assessments will be performed by the same periodontist AMRJ
Data from the clinical treatment were registered in patient records In parallel clinical data were documented in a study protocol and saved in a safe in accordance with standard operation procedure at the clinicThe protocol with medical records were not opened until the study was completed and only by authorized persons with access to the data in the study such as principal investigator and statisticians
In accordance with an international working group diagnosis of peri-implantitis should include pocket depth bleeding and bone loss X-ray Thus in this study the primary outcomes are radiographic evidence of bone fill and changes in probing depths at implants treated
Parametric tests independent t-tests equal variance not assumed and non-parametric tests Mann-Whitney U-test Wilcoxon test will be performed to assess differences over time and between groups Statistical significance will be declared at p lt005 The Kolmogorov- Smirnov test will be used to define if the data presented with normal distribution or not The SPSS PASW 290 statistical software SPSS Inc Chicago IL USA for Apple computer will be used in the analysis
Patients that will participate in the study will consecutively be given an ID code and data will be registered in the ordinary patient journal The code list will be placed in a locked up space at the clinic
All patients will be given oral and written information about the study and will sign a written informed consent The patients will be informed that they could drop off when ever they want without any explanations The ethical board approved the study
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