NCT06783426

Brief Summary

The aim of this study is to gain knowledge and understanding about older adults' experiences of comprehensive oral prosthetic rehabilitation and their life situation before, during and after the treatment. This is both to deepen the knowledge gained in an ongoing interventional study, but also to increase the understanding of how to best meet older adults' needs when planning and performing oral rehabilitation in any dental surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

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

October 9, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2025

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

January 9, 2025

Last Update Submit

February 9, 2026

Conditions

Keywords

Qualitative studyInterview studyQuality of LifePatient experienceoral rehabilitation

Outcome Measures

Primary Outcomes (1)

  • The participants perceived experiences

    Since this is a qualitative study, we have no traditional outcome measures. Instead, completing the interview and sharing their perceived experiences during the treatment procedure , how their oral health may have affected their life situation, their quality of life and well-being before, during and after the treatment may serve as our primary outcome measure.

    3-9 months after completing the prosthetic treatment.

Study Arms (1)

Older adults who have undergone extensive oral rehabilitation

The cohort includes older adults, who have been referred to the Eastman Institute in Stockholm for extensive oral prosthetic rehabilitation. They have previously agreed to participate in the intervention study "Cognitive changes and neural correlates after oral rehabilitation procedures in older adults" at the Eastman Institute in Stockholm . The oral rehabilitation usually includes fixed prosthodontics. These patients are asked to participate in one interview after their treatment is completed to share their experiences before, during, and after the treatment.

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants have been assessed with comprehensive quantitative methods of their neuropsychological status, oral function, and quality of life in conjunction with the original study from which they were recruited. They were then treated with oral prosthetic therapy and are reassessed at a follow-up three months after completion of the therapy. Our participants are recruited consecutively as they finish treatment at the Eastman Institute until we consider to have obtained "saturation" of our results.

You may qualify if:

  • Completed prosthetic treatment in the original study 2-12 months ago
  • Age 65-80 years at start of the original study
  • Masticatory dysfunction (Eichner's index B3-B4 or C1-C4) for original study
  • Mini-Mental-State-Examination-test (MMSE) score \>26 for original study

You may not qualify if:

  • Neuropsychological disease
  • Severely impaired hearing or vision
  • Poor knowledge of the Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Folktandvården Stockholms Län AB

Stockholm, Sweden

Location

Related Publications (6)

  • Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.

    PMID: 14769454BACKGROUND
  • Elgestad Stjernfeldt P, Faxen-Irving G, Wardh I. Masticatory ability in older individuals: A qualitative interview study. Gerodontology. 2021 Jun;38(2):199-208. doi: 10.1111/ger.12515. Epub 2020 Nov 27.

    PMID: 33245159BACKGROUND
  • Hyland R, Ellis J, Thomason M, El-Feky A, Moynihan P. A qualitative study on patient perspectives of how conventional and implant-supported dentures affect eating. J Dent. 2009 Sep;37(9):718-23. doi: 10.1016/j.jdent.2009.05.028. Epub 2009 Jun 7.

    PMID: 19559515BACKGROUND
  • Trulsson U, Engstrand P, Berggren U, Nannmark U, Branemark PI. Edentulousness and oral rehabilitation: experiences from the patients' perspective. Eur J Oral Sci. 2002 Dec;110(6):417-24. doi: 10.1034/j.1600-0722.2002.21394.x.

    PMID: 12507214BACKGROUND
  • Nordenram G, Davidson T, Gynther G, Helgesson G, Hultin M, Jemt T, Lekholm U, Nilner K, Norlund A, Rohlin M, Sunnegardh-Gronberg K, Tranaeus S. Qualitative studies of patients' perceptions of loss of teeth, the edentulous state and prosthetic rehabilitation: a systematic review with meta-synthesis. Acta Odontol Scand. 2013 May-Jul;71(3-4):937-51. doi: 10.3109/00016357.2012.734421. Epub 2012 Oct 29.

    PMID: 23101439BACKGROUND
  • Hedberg L, Ekman U, Nordin LE, Smedberg JI, Skott P, Seiger A, Sandborgh-Englund G, Westman E, Kumar A, Trulsson M. Cognitive changes and neural correlates after oral rehabilitation procedures in older adults: a protocol for an interventional study. BMC Oral Health. 2021 Jun 9;21(1):297. doi: 10.1186/s12903-021-01654-5.

    PMID: 34107933BACKGROUND

Study Officials

  • Charlotta Elleby, PhD, DDS

    Folktandvården Stockholm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 20, 2025

Study Start

October 9, 2024

Primary Completion

May 19, 2025

Study Completion

May 19, 2025

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations