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Recruiting NCT06688669

Examining the Effects of Removable Denture Use in Patients Over 60 Years of Age

— Observational Edentulism Denture, Complete Denture, Partial, Removable

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fabrication of suitable complete or removable partial dentures for the patient.
Who it may be relevant to
Registry conditions: Edentulism, Denture, Complete, Denture, Partial, Removable. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Examining the Effects of Removable Denture on Behavior and Cognitive Skills in Geriatric Patients

Overview

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.

Interventions

  • Other Fabrication of suitable complete or removable partial dentures for the patient
    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.

Primary outcome measures

  • 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 Timed up and go (TUG) test in individuals after the use of dentures [Time frame: From enrollment to three months after]
Secondary outcome measures (2)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul University Faculty of Dentistry — Istanbul

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. PMID 37719519

Identifiers

NCT: NCT06688669 · 2024/47/Rev-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗