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Patient Reported Outcome MeasuresNCT06571201

Patient-reported Outcomes and Esthetics With Single Dental Implants

An observational study of Patient Reported Outcome Measures and Patient Satisfaction, run by Kristianstad University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 23 to 100 years
How many people
45 participants
Where
1 siteSweden
Study dates
15 Aug 2006to 7 Jun 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 23 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Kristianstad University

    Kristianstad

Other trials in Sweden

About this study

Official title: Patient-reported Outcomes and Esthetics With Single Dental Implants 10-15 Years After Placement, a Cross-sectional Study

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.

Read the 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.

Keywords
dental esthetics, patient reported outcome measurements, single dental implant
Medical subject headings
Patient Satisfaction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient- reported outcomes concerning function and cleaning of dental single implants

    Visual Analogue Scale 0=yes absolutely 10= absolutely not. Maximum=100 scores Minimum=0 scores

    Measured: At the dental examination

  2. Patient- reported outcomes concerning esthetics of dental single implants

    Visual Analogue Scale 0=not satisfied at all. 10=completely satisfied Maximum=40 scores Minimum=0 scores

    Measured: At the dental examination

Secondary outcomes (1)

  1. Pink and white esthetic scores for single dental implants

    PES/WES index Belser et al. 2009 0=worst outcome and 2=best outcome reported by a dentist from intraoral photographs

    Measured: 15 years later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start15 Aug 2006
  3. Primary completion7 Jun 2007
  4. Study completion7 Jun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06571201
Sponsor's protocol ID
Single dental implants
Status last verified
Mar 2025
First submitted
22 Aug 2024
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19120783

  • 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.

    PubMed 19228100

  • 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.

    PubMed 34145925

  • 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.

    PubMed 30613918

  • 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.

    PubMed 15777328

  • 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.

    PubMed 29493024

Questions about this trial

What is this clinical trial studying?

An observational study of Patient Reported Outcome Measures and Patient Satisfaction, run by Kristianstad University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient- reported outcomes concerning function and cleaning of dental single implants (time frame: At the dental examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06571201, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.

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