- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06783426
Older Adults' Experiences of Oral Rehabilitation - a Qualitative Interview Study
March 31, 2026 updated by: Folktandvården Stockholms län AB
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.
Study Overview
Status
Completed
Conditions
Detailed Description
This qualitative study will be based on individual, semi-structured interviews using an Interview Guide focusing on the participants´ perceptions, experiences, and reflections.
The interviews will then be analyzed with a descriptive content analysis method according to Graneheim and Lundman.
Study Type
Observational
Enrollment (Actual)
8
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Stockholm, Sweden
- Folktandvården Stockholms län AB
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
Inclusion Criteria:
- Completed prosthetic treatment in the original study 3-13 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
Exclusion criteria for the original study:
- Neuropsychological disease
- Severely impaired hearing or vision
- Poor knowledge of the Swedish language
- Having had a stroke ≤ 6 months before inclusion
No additional exclusion criteria for our study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The participants' perceived experiences
Time Frame: 3-13 months after completing the prosthetic treatment.
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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.
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3-13 months after completing the prosthetic treatment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charlotta Elleby, PhD, DDS, Folktandvården Stockholm
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2024
Primary Completion (Actual)
May 19, 2025
Study Completion (Actual)
May 19, 2025
Study Registration Dates
First Submitted
January 9, 2025
First Submitted That Met QC Criteria
January 17, 2025
First Posted (Actual)
January 20, 2025
Study Record Updates
Last Update Posted (Actual)
April 6, 2026
Last Update Submitted That Met QC Criteria
March 31, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- FTV 2407-0291
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Our recordings of the interviews may contain sensitive data, and the participants could be identified by voice.
According to the approved ethical application we are not supposed to share any data that can be used to identify the participants.
However, it is possible that the de-identified transcriptions of the interviews could be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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