NCT06571201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2007

Completed
17.2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

August 22, 2024

Last Update Submit

March 4, 2025

Conditions

Keywords

dental estheticspatient reported outcome measurementssingle dental implant

Outcome Measures

Primary Outcomes (2)

  • 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

    At the dental examination

  • 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

    At the dental examination

Secondary Outcomes (1)

  • Pink and white esthetic scores for single dental implants

    15 years later

Eligibility Criteria

Age23 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristianstad University

Kristianstad, Sweden

Location

Related Publications (6)

  • 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.

    PMID: 19120783BACKGROUND
  • 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.

    PMID: 19228100BACKGROUND
  • 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.

    PMID: 34145925BACKGROUND
  • 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.

    PMID: 30613918BACKGROUND
  • 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.

    PMID: 15777328BACKGROUND
  • 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.

    PMID: 29493024BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Viveca Wallin Bengtsson, phD

    University of Kristianstad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator, phD

Study Record Dates

First Submitted

August 22, 2024

First Posted

August 26, 2024

Study Start

August 15, 2006

Primary Completion

June 7, 2007

Study Completion

June 7, 2007

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations