Clinical trial NCT06688669: Examining the Effects of Removable Denture Use in Patients Over 60 Years of Age
Official title: Examining the Effects of Removable Denture on Behavior and Cognitive Skills in Geriatric Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Edentulism
Denture, Complete
Denture, Partial, Removable
Keywords: complete denture
removable partial denture
OHIP-14
mini mental state examination
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 60 who apply to Istanbul University Faculty of Dentistry to receive removable dentures.

Brief 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. 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: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Evaluation of mini mental state examination (MMSE) test, in individuals after the use of dentures
timeFrame: From enrollment to three months after
measure: Evaluation of Timed up and go (TUG) test in individuals after the use of dentures
timeFrame: From enrollment to three months after
Secondary outcomes:
measure: Adaptation of dentures in geriatric patients
timeFrame: From enrollment to three months after
measure: Evaluation of Oral Functional Capacity (OFC) in individuals after the use of dentures
timeFrame: From enrollment to three months after
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Faculty of Dentistry
state: Vezneciler
Study officials:
affiliation: Istanbul University
name: Olcay Şakar, Prof. Dr. Clinical Professor
role: STUDY_CHAIR
References:
citation: 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.