A study of changes in the nutrition status of patients with complete dentures by denture replacement and dietary advice

Not Applicable

Recruiting

• Conditions: Maxillary or mandibular edentulous; Edentulous; D007575

• Registration Number: JPRN-jRCT1032230495
• Lead Sponsor: Matsumoto Takashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-06
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Patients with an edentulous maxilla or mandible who visits the Prosthodontics Department of Showa University Dental Hospital
Patients with functioning dentures available at the time of consent
Patients who have given written consent to participate in this study

Exclusion Criteria

Patients residing in nursing homes
Patients receiving dietary advice from a doctor at the time of consent
Patients with implant overdentures
Patients with dementia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study compares the changes in serum albumin value from baseline between the group where patients receive a dietary advice after new denture delivery (Group A) and the group where parients receive a dietary advice (Group B).

Secondary Outcome Measures

Name	Time	Method
(1) Evaluation of nutritional status<br>a. Blood tests: prealbumin, serum total protein, cholinesterase, total cholesterol, zinc, serum calcium, folic acid, retinol binding protein, transferrin, HDL/LDL cholesterol, white blood cell count, white blood cell picture, total peripheral blood lymphocyte count, hemoglobin level, serum vitamin C, amino acid analysis, C-reactive protein<br>b. Body mass index (BMI)<br>c. Assessment of dietary intake: Evaluation using Brief-type Self-administered Diet History Questionnaire (BDHQ)<br>(2) Assessment of living environment: Evaluation using self-administered questionnaire<br>(3) Subjective evaluation of denture quality (patient, dentist): Esthetic and stability evaluation using Visual Analog Scale (VAS)<br>(4) Evaluation of oral-related quality of life: Evaluation using Oral Health Impact Profile (OHIP)<br>(5) Evaluation of masticatory function: glucose elution from gummy jelly chewing, occlusal force, occlusal contact area