Clinical trial NCT06571201: Patient-reported Outcomes and Esthetics With Single Dental Implants
Official title: Patient-reported Outcomes and Esthetics With Single Dental Implants 10-15 Years After Placement, a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Reported Outcome Measures
Patient Satisfaction
Implant Complication
Keywords: dental esthetics
patient reported outcome measurements
single dental implant
Lead sponsor: Kristianstad University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 45
Sex: ALL
Minimum age (years): 23
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing prosthetic single dental implant treatment at an Oral Prosthodontic Specialist Clinic in Kristianstad (Folktandvården, Public Dental Service Kristianstad, Sweden) between 1991-1996

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient- reported outcomes concerning function and cleaning of dental single implants
timeFrame: At the dental examination
measure: Patient- reported outcomes concerning esthetics of dental single implants
timeFrame: At the dental examination
Secondary outcomes:
measure: Pink and white esthetic scores for single dental implants
timeFrame: 15 years later
Other outcomes:
Locations:
city: Kristianstad
country: Sweden
facility: Kristianstad University
Study officials:
affiliation: University of Kristianstad
name: Viveca Wallin Bengtsson, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gehrke P, Lobert M, Dhom G. Reproducibility of the pink esthetic score--rating soft tissue esthetics around single-implant restorations with regard to dental observer specialization. J Esthet Restor Dent. 2008;20(6):375-84; discussion 385. doi: 10.1111/j.1708-8240.2008.00212.x.
citation: Belser UC, Grutter L, Vailati F, Bornstein MM, Weber HP, Buser D. Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores. J Periodontol. 2009 Jan;80(1):140-51. doi: 10.1902/jop.2009.080435.
citation: Thoma DS, Cosyn J, Fickl S, Jensen SS, Jung RE, Raghoebar GM, Rocchietta I, Roccuzzo M, Sanz M, Sanz-Sanchez I, Scarlat P, Schou S, Stefanini M, Strasding M, Bertl K; working group 2 of the 6th EAO Consensus Conference 2021. Soft tissue management at implants: Summary and consensus statements of group 2. The 6th EAO Consensus Conference 2021. Clin Oral Implants Res. 2021 Oct;32 Suppl 21(Suppl 21):174-180. doi: 10.1111/clr.13798.
citation: Altay MA, Sindel A, Tezerisener HA, Yildirimyan N, Ozarslan MM. Esthetic evaluation of implant-supported single crowns: a comparison of objective and patient-reported outcomes. Int J Implant Dent. 2019 Jan 7;5(1):2. doi: 10.1186/s40729-018-0153-3.
citation: Pjetursson BE, Karoussis I, Burgin W, Bragger U, Lang NP. Patients' satisfaction following implant therapy. A 10-year prospective cohort study. Clin Oral Implants Res. 2005 Apr;16(2):185-93. doi: 10.1111/j.1600-0501.2004.01094.x.
citation: Stefanini M, Felice P, Mazzotti C, Mounssif I, Marzadori M, Zucchelli G. Esthetic evaluation and patient-centered outcomes in single-tooth implant rehabilitation in the esthetic area. Periodontol 2000. 2018 Jun;77(1):150-164. doi: 10.1111/prd.12215. Epub 2018 Feb 28.