EdentulismNCT06688669
Examining the Effects of Removable Denture Use in Patients Over 60 Years of Age
An observational study of Edentulism and Denture, Complete, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Patients over the age of 60 who do not currently have any removable dentures but require them will be included in the study. Patients who will receive complete dentures and those who will receive partial dentures will be assessed in separate groups. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Edentulism, Denture, Complete, Denture, Partial, Removable
- What is being tested?
- Fabrication of suitable complete or removable partial dentures for the patient
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 30 Sep 2025
- How long will I take part?
- 3 Months
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 60 who apply to Istanbul University Faculty of Dentistry to receive removable dentures.
Who may be able to join
- Patients over the age of 60
- No systemic condition that would prevent the fabrication of removable dentures
- Need for new removable dentures for both jaws
- Ability to read and understand the questions in the tests and surveys
- No barriers to communication or self-expression
- No significant physical disability affecting functionality
- No history of cancer or surgical operation in the head and neck region
- No conditions or medications that could limit test performance (e.g., Parkinson's disease)
Who cannot join
- Patients under the age of 60
- Patients who do not require new removable dentures
- Patients whose missing teeth can be restored with fixed prosthetic restorations and who do not need removable dentures
- Patients who are illiterate
- Patients with systemic conditions that prevent the fabrication of removable dentures
- Patients with conditions like Parkinson's disease that could restrict test performance or who use medications with side effects causing unwanted convulsions
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- Patients with significant balance issues, who frequently lose balance while walking
- Geriatric patients with temporary or permanent memory loss
- Patients with any history of cancer in the head and neck region
- Patients with severe difficulty in communication and self-expression
- Patients who are not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Dentistry
Istanbul, Vezneciler
About this study
Official title: Examining the Effects of Removable Denture on Behavior and Cognitive Skills in Geriatric Patients
Patients over the age of 60 who do not currently have any removable dentures but require them will be included in the study. Patients who will receive complete dentures and those who will receive partial dentures will be assessed in separate groups. Before the fabrication of the dentures, the Mini-Mental State Examination Test (MMSE), the physical normative value test (TUG), and the Oral Functional Capacity (OFC) scoring will be conducted. No intervention will be made to the treatment during the prosthetic treatment process.
The same questionnaires will be administered again three weeks after the completion of the prosthetic treatments. The impact of the use of removable dentures on test results will be evaluated. Additionally, during this session, patients will complete a patient satisfaction test regarding their dentures (OHIP-14 for patients with a removable partial denture indication, and OHIP-edent for patients with a complete denture indication). Patients will be called back after three months, and all tests will be repeated. The relationship between the Mini-Mental State Examination, the TUG test, and the OFC test with patient satisfaction will be assessed and any changes in test scores related to denture use will be investigated.
- Conditions
- Edentulism, Denture, Complete, Denture, Partial, Removable
- Being tested
- Fabrication of suitable complete or removable partial dentures for the patient
- Keywords
- complete denture, removable partial denture, OHIP-14, mini mental state examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fabrication of suitable complete or removable partial dentures for the patientOther
Fabrication of suitable complete and partial dentures for the patient. The study will not interfere with this treatment process; only follow-up assessments will be conducted at specific intervals after the dentures are fabricated, and surveys will be administered to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with complete denture | Patients with total edentulism who require complete dentures. Receives: Other: Fabrication of suitable complete or removable partial dentures for the patient | |
| Patients with removable partial dentures | Patients with partial edentulism who require removable-partial dentures. Receives: Other: Fabrication of suitable complete or removable partial dentures for the patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of mini mental state examination (MMSE) test, in individuals after the use of dentures
Evaluation of the effects of complete dentures and removable partial dentures on patients' cognitive status using the Mini-Mental State Examination (MMSE) test. Patients will first undergo the 10-question Mini Mental State Examination (MMSE) test. The Mini Mental State Examination assesses cognitive status by measuring verbal fluency, executive functions, and visuospatial skills. This test will evaluate the cognitive condition of the patient. The MMSE is a brief, 10-question test that takes approximately 5 minutes to complete. It will be administered through a question-and-answer format. A total score will be calculated, and statistical analysis will be conducted based on this total score. An increase in the score will indicate an improvement in cognitive status.
Measured: From enrollment to three months after
Evaluation of Timed up and go (TUG) test in individuals after the use of dentures
Evaluation of the effects of complete dentures and removable partial dentures on patients' dynamic functions using the Timed Up and Go (TUG) test.
Measured: From enrollment to three months after
Secondary outcomes (2)
Adaptation of dentures in geriatric patients
Examining the changes in geriatric patients' adaptation to their new dentures over time and correlating their adaptation (OHIP-14 results) with their cognitive or functional status before treatment.The OHIP-14 test is frequently used to assess satisfaction with removable dentures. Based on the answers to the questions in this test, patient satisfaction is scored, with higher scores indicating greater satisfaction.
Measured: From enrollment to three months after
Evaluation of Oral Functional Capacity (OFC) in individuals after the use of dentures
Evaluation of the effects of dentures on on patients' oral functional capacities (OFC).The OFC assessment is conducted as follows: Parameters under the titles of therapeutic capacity, oral hygiene ability, and self-responsibility are evaluated by the clinician and rated as 'reduced,' 'significantly reduced,' 'normal,' or 'absent,' with a score out of 4. Since the evaluation is conducted by the clinician, it does not present any additional challenge to the patients and takes approximately 5 minutes. Two researchers will independently assign an OFC score based on the patient's responses, aiming for consistency between the two scores. This scoring method has been used in all studies conducted with OFC (each category will be scored separately out of 4, and the average of the three scores will be taken). The results of the three tests will be evaluated through separate statistical analyses."
Measured: From enrollment to three months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Mar 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EdentulismStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berk Bilgen, Istanbul University
- Investigators
- Olcay Şakar, Prof. Dr. Clinical Professor, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688669
- Sponsor's protocol ID
- 2024/47/Rev-1
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ahmed SE, Raju R, Kurien A, M K, Bano S, Shalma H. Impact of Denture Prostheses on Cognitive Functioning in Completely Edentulous Patients: A Pilot Study. Cureus. 2023 Aug 16;15(8):e43570. doi: 10.7759/cureus.43570. eCollection 2023 Aug.
PubMed 37719519Bilgen B, Sezgin AO, Sakar O. Cognitive, Functional Mobility and Oral Functional Capacity Changes Following Complete Denture Rehabilitation: A Prospective Longitudinal Study. J Oral Rehabil. 2026 Sep 29. doi: 10.1111/joor.70327. Online ahead of print.
PubMed 42810851
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Removable Denture on Behavior and Cognitive Skills in Geriatric Patients
- ClinicalTrials.gov ID
- NCT06688669
- Acronym / sponsor ID
- 2024/47/Rev-1
- Conditions
- Edentulism, Denture, Complete, Denture, Partial, Removable
- Keywords
- complete denture, removable partial denture, OHIP-14, mini mental state examination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 14 Nov 2024 (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.
Patients over the age of 60 who do not currently have any removable dentures but require them will be included in the study. Patients who will receive complete dentures and those who will receive partial dentures will be assessed in separate groups. Before the fabrication of the dentures, the Mini-Mental State Examination Test (MMSE), the physical normative value test (TUG), and the Oral Functional Capacity (OFC) scoring will be conducted. No intervention will be made to the treatment during the prosthetic treatment process.
The same questionnaires will be administered again three weeks after the completion of the prosthetic treatments. The impact of the use of removable dentures on test results will be evaluated. Additionally, during this session, patients will complete a patient satisfaction test regarding their dentures (OHIP-14 for patients with a removable partial denture indication, and OHIP-edent for patients with a complete denture indication). Patients will be called back after three months, and all tests will be repeated. The relationship between the Mini-Mental State Examination, the TUG test, and the OFC test with patient satisfaction will be assessed and any changes in test scores related to denture use will be investigated.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with complete denture | – | Other: Fabrication of suitable complete or removable partial dentures for the patientPatients with total edentulism who require complete dentures. |
| Patients with removable partial dentures | – | Other: Fabrication of suitable complete or removable partial dentures for the patientPatients with partial edentulism who require removable-partial dentures. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 60 who apply to Istanbul University Faculty of Dentistry to receive removable dentures.
Key inclusion criteria (8 listed)
- Patients over the age of 60
- No systemic condition that would prevent the fabrication of removable dentures
- Need for new removable dentures for both jaws
- Ability to read and understand the questions in the tests and surveys
- No barriers to communication or self-expression
Key exclusion criteria (11 listed)
- Patients under the age of 60
- Patients who do not require new removable dentures
- Patients whose missing teeth can be restored with fixed prosthetic restorations and who do not need removable dentures
- Patients who are illiterate
- Patients with systemic conditions that prevent the fabrication of removable dentures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fabrication of suitable complete or removable partial dentures for the patientFabrication of suitable complete and partial dentures for the patient. The study will not interfere with this treatment process; only follow-up assessments will be conducted at specific intervals after the dentures are fabricated, and surveys will be administered to the patient. | Other | Patients with complete denture, Patients with removable partial dentures |
Primary outcome
Evaluation of mini mental state examination (MMSE) test, in individuals after the use of dentures
Time frame: From enrollment to three months after
Evaluation of the effects of complete dentures and removable partial dentures on patients' cognitive status using the Mini-Mental State Examination (MMSE) test. Patients will first undergo the 10-question Mini Mental State Examination (MMSE) test. The Mini Mental State Examination assesses cognitive status by measuring verbal fluency, executive functions, and visuospatial skills. This test will evaluate the cognitive condition of the patient. The MMSE is a brief, 10-question test that takes approximately 5 minutes to complete. It will be administered through a question-and-answer format. A total score will be calculated, and statistical analysis will be conducted based on this total score. An increase in the score will indicate an improvement in cognitive status.
Evaluation of Timed up and go (TUG) test in individuals after the use of dentures
Time frame: From enrollment to three months after
Evaluation of the effects of complete dentures and removable partial dentures on patients' dynamic functions using the Timed Up and Go (TUG) test.
2 secondary outcomes
Adaptation of dentures in geriatric patients
Time frame: From enrollment to three months after
Evaluation of Oral Functional Capacity (OFC) in individuals after the use of dentures
Time frame: From enrollment to three months after
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 27 Aug 2026.
- Results publication: PubMed 37719519Ahmed SE, Raju R, Kurien A, M K, Bano S, Shalma H. Impact of Denture Prostheses on Cognitive Functioning in Completely Edentulous Patients: A Pilot Study. Cureus. 2023 Aug 16;15(8):e43570. doi: 10.7759/cureus.43570. eCollection 2023 Aug.
- Derived from this study: PubMed 42810851Bilgen B, Sezgin AO, Sakar O. Cognitive, Functional Mobility and Oral Functional Capacity Changes Following Complete Denture Rehabilitation: A Prospective Longitudinal Study. J Oral Rehabil. 2026 Sep 29. doi: 10.1111/joor.70327. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Olcay Şakar, Prof. Dr. Clinical Professor study chair
Istanbul University
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 Edentulism and Denture, Complete, run by Istanbul University at 1 site in Turkey (Türkiye).
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 8 inclusion and 11 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 27 Aug 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 Turkey (Türkiye). 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?
Evaluation of mini mental state examination (MMSE) test, in individuals after the use of dentures (time frame: From enrollment to three months after). 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 NCT06688669, which also lists 2 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 27 Aug 2026.