Patient-reported Outcomes and Esthetics With Single Dental Implants

Completed

• Conditions: Implant Complication; Patient Satisfaction; Patient Reported Outcome Measures

• Registration Number: NCT06571201
• Lead Sponsor: Kristianstad University

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 Esthetic/White Esthetic Score Index 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 score/white esthetic score (PES/WES) index.

Peri-implant mucositis was established if the presence of bleeding (BOP) and/or 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. In this study, this was defined as ≤ 2.5 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.

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 28.0 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). Pearson's 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 0.05. No data were missing. Cronbach's alpha was used to test the reproducibility of the PES/WES index used for the objective assessment of the esthetic outcome.

Study Timeline

• Study Start: 2006-08-15
• Primary Completion: 2007-06-07
• Study Completion: 2007-06-07
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• if only one single dental implant reconstruction in the esthetic zone, defined as teeth from the area of the upper right canine to the upper left canine
• if have filled in two questionnaires
• if answered an oral questionnaire
• if had intraoral photographs taken

Exclusion Criteria

-if there was an edentulous area next to the implant to be studied

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient- reported outcomes concerning esthetics of dental single implants	At the dental examination	Visual Analogue Scale 0=not satisfied at all. 10=completely satisfied Maximum=40 scores Minimum=0 scores
Patient- reported outcomes concerning function and cleaning of dental single implants	At the dental examination	Visual Analogue Scale 0=yes absolutely 10= absolutely not. Maximum=100 scores Minimum=0 scores

Secondary Outcome Measures

Name	Time	Method
Pink and white esthetic scores for single dental implants	15 years later	PES/WES index Belser et al. 2009 0=worst outcome and 2=best outcome reported by a dentist from intraoral photographs

Trial Locations

Locations (1)

Kristianstad University; 🇸🇪 Kristianstad, Sweden