Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571201
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Patient-reported Outcomes and Esthetics With Single Dental Implants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patient-reported Outcomes and Esthetics With Single Dental Implants 10-15 Years After Placement a Cross-sectional Study
Status:
COMPLETED
Status Verified Date:
2024-08
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 goal of this observational study is to investigate patient-reported long-term outcomes of single dental implants Therefore the aim of the study is to describe patient-reported functional and esthetic outcomes of single dental implants A secondary aim is to evaluate the objective esthetics of single dental implants
The primary outcomes are patient-reported experiences regarding the function cleaning ability and esthetics of the single dental implant The esthetics of the single dental implant will also be assessed using the Pink EstheticWhite Esthetic Score Index Belser et al 2009 and considered secondary outcome
The primary outcomes are patient-reported experiences regarding the function cleaning ability and esthetics of the single dental implant The esthetics of the single dental implant will also be assessed using the Pink EstheticWhite Esthetic Score Index Belser et al 2009 and considered secondary outcome
Detailed Description:
Participants with one single-dental implant in the esthetic zone were selected A clinical examination was performed and presence of bleeding BOP probing pocket depth PPD and presence of suppuration was registered Two questionnaires with visual analogue scales VAS were filled in by the participants and intraoral photographs were taken One of the questionnaires related to satisfaction with function and leaning and the other involved the esthetics of the single dental implant One dentist reviewed the photographs using the pink esthetic scorewhite esthetic score PESWES index Belser et al 2009
Peri-implant mucositis was established if the presence of bleeding BOP andor suppuration on gentle probing and the absence of bone loss beyond crestal bone level changes resulting from initial bone remodeling at the implant according to the latest definition of Peri-Implant Diseases and Conditions Berglundh et al 2014 In this study this was defined as 25 mm apical of the most coronal portion of the intra-osseous part of the implant
A diagnosis of peri-implantitis was established if the presence of bleeding on gentle probing BOP and bone levels of 3 mm apical of the most coronal portion of the intra-osseous part of the implant according to the latest classification of Peri-Implant Diseases and Conditions Berglundh et al 2014
Parallel to medical records all data was saved in a safe together with a code list The data was not opened until the study was completed and only by authorized persons with access to the data in the study such as the principal investigator and the statisticians
All participants was given oral and written information about the study and signed a written informed consent The participants was informed that they could drop off whenever they wanted without any explanations The ethical board approved the study and the investigation was performed according to the principles of the Declaration of Helsinki on experimentation involving human subjects
The IBM SPSS version 280 statistical software package SPSS Inc Armonk NY USA for personal computer was used in the statistical analyses The data were analyzed using descriptive statistics with the mean and standard deviation SD Pearsons χ2 test and Mantel-Haenszel common odds ratios were used to analyze dichotomous data For categorical data percentages are given Estimates odds ratio mean difference are given with the corresponding 95 confidence interval The significance level for the p value was set at 005 No data were missing Cronbachs alpha was used to test the reproducibility of the PESWES index used for the objective assessment of the esthetic outcome
Peri-implant mucositis was established if the presence of bleeding BOP andor suppuration on gentle probing and the absence of bone loss beyond crestal bone level changes resulting from initial bone remodeling at the implant according to the latest definition of Peri-Implant Diseases and Conditions Berglundh et al 2014 In this study this was defined as 25 mm apical of the most coronal portion of the intra-osseous part of the implant
A diagnosis of peri-implantitis was established if the presence of bleeding on gentle probing BOP and bone levels of 3 mm apical of the most coronal portion of the intra-osseous part of the implant according to the latest classification of Peri-Implant Diseases and Conditions Berglundh et al 2014
Parallel to medical records all data was saved in a safe together with a code list The data was not opened until the study was completed and only by authorized persons with access to the data in the study such as the principal investigator and the statisticians
All participants was given oral and written information about the study and signed a written informed consent The participants was informed that they could drop off whenever they wanted without any explanations The ethical board approved the study and the investigation was performed according to the principles of the Declaration of Helsinki on experimentation involving human subjects
The IBM SPSS version 280 statistical software package SPSS Inc Armonk NY USA for personal computer was used in the statistical analyses The data were analyzed using descriptive statistics with the mean and standard deviation SD Pearsons χ2 test and Mantel-Haenszel common odds ratios were used to analyze dichotomous data For categorical data percentages are given Estimates odds ratio mean difference are given with the corresponding 95 confidence interval The significance level for the p value was set at 005 No data were missing Cronbachs alpha was used to test the reproducibility of the PESWES index used for the objective assessment of the esthetic outcome
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