Examining the Effects of Removable Denture Use in Patients Over 60 Years of Age
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorIstanbul University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients over the age of 60 who apply to Istanbul University Faculty of Dentistry to receive removable dentures.
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Fabrication of suitable complete or removable partial dentures for the patient
Other interventionFabrication 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Patients with complete denture1 intervention
Group B: Patients with removable partial dentures1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to three months after2
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.
Time frame
From enrollment to three months afterSecondary outcomes
1
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.
Time frame
From enrollment to three months after2
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."
Time frame
From enrollment to three months afterSponsors and contacts
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Source ClinicalTrials.gov