Oral HealthNCT06783426
Older Adults' Experiences of Oral Rehabilitation - a Qualitative Interview Study
An observational study of Oral Health, run by Folktandvården Stockholms län AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Oral Health
- Type of treatment
- Pill or oral medicine
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- 9 Oct 2024to 19 May 2025
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Oral Health
- Keywords
- Qualitative study, Interview study, Quality of Life, Patient experience, oral rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-13 months after completing the prosthetic treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start9 Oct 2024
- Primary completion19 May 2025
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Folktandvården Stockholms län AB
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Charlotta Elleby, PhD, DDS, Principal investigator, Folktandvården Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783426
- Sponsor's protocol ID
- FTV 2407-0291
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 14769454Elgestad 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.
PubMed 33245159Hyland 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.
PubMed 19559515Trulsson 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.
PubMed 12507214Nordenram 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.
PubMed 23101439Hedberg 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.
PubMed 34107933Hedberg L, Elleby C, Trulsson M, Kumar A, Ekman U, Cronfalk Seiger B, Skott P. Experiences of Fixed Oral Rehabilitation in Older Persons - Motivation, Procedural Strains and Rewarding Improvements. J Oral Rehabil. 2026 Sep 7. doi: 10.1111/joor.70283. Online ahead of print.
PubMed 42705846
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Older Adults' Experiences of Oral Rehabilitation - a Qualitative Interview Study
- ClinicalTrials.gov ID
- NCT06783426
- Acronym / sponsor ID
- FTV 2407-0291
- Conditions
- Oral Health
- Keywords
- Qualitative study, Interview study, Quality of Life, Patient experience, oral rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Folktandvården Stockholms län ABOther government
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The participants' perceived experiences
Time frame: 3-13 months after completing the prosthetic treatment.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 14769454Graneheim 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.
- Background: PubMed 33245159Elgestad 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.
- Background: PubMed 19559515Hyland 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.
- Background: PubMed 12507214Trulsson 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.
- Background: PubMed 23101439Nordenram 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.
- Background: PubMed 34107933Hedberg 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.
- Derived from this study: PubMed 42705846Hedberg L, Elleby C, Trulsson M, Kumar A, Ekman U, Cronfalk Seiger B, Skott P. Experiences of Fixed Oral Rehabilitation in Older Persons - Motivation, Procedural Strains and Rewarding Improvements. J Oral Rehabil. 2026 Sep 7. doi: 10.1111/joor.70283. Online ahead of print.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotta Elleby, PhD, DDS principal investigator
Folktandvården Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health, run by Folktandvården Stockholms län AB 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 5 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 Apr 2026. 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?
The participants' perceived experiences (time frame: 3-13 months after completing the prosthetic treatment.). 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 NCT06783426, which also lists 7 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 Apr 2026.