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

NCT06688669 | Recruiting

• 1 other identifier: 2024/47/Rev-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulism; Denture, Complete; Denture, Partial, Removable

Keywords

complete denture; removable partial denture; OHIP-14; mini mental state examination

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to three months after

Secondary Outcomes (2)

• Adaptation of dentures in geriatric patients

  From enrollment to three months after

• Evaluation of Oral Functional Capacity (OFC) in individuals after the use of dentures

  From enrollment to three months after

Study Arms (2)

Patients with complete denture

Patients with total edentulism who require complete dentures.

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.

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

Interventions

Fabrication of suitable complete or removable partial dentures for the patient OTHER

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.

Patients with complete denture; Patients with removable partial dentures

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Dentistry

Istanbul, Vezneciler, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Interventions

Denture, Partial, Removable

Intervention Hierarchy (Ancestors)

Denture, Partial; Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Olcay Şakar, Prof. Dr. Clinical Professor

  Istanbul University

  STUDY CHAIR

Central Study Contacts

Berk Bilgen, PhD. DDS. Research Assistant

CONTACT

+905385492774; berk.bilgen@istanbul.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD DDS, Principal Investigator

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 14, 2024
• Study Start: October 25, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

TU (1)