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

A randomized controlled trial of changes in nutritional status of edentulous patients by prosthodontic treatment and dietary counseling

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032230495
Enrollment
48
Registered
2023-12-06
Start date
2023-12-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary or mandibular edentulous Edentulous

Interventions

Fabrication of complete dentures Dietary advice (diet therapy)
D003824, D004035
complete denture fabrication, dietary advice

Sponsors

Matsumoto Takashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with an edentulous maxilla or mandible who visits the Prosthodontics or Oral Function Management 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
(1) Evaluation of nutritional status 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 b. Body mass index (BMI) c. Assessment of dietary intake: Evaluation using Brief-type Self-administered Diet History Questionnaire (BDHQ) (2) Assessment of living environment: Evaluation using self-administered questionnaire (3) Subjective evaluation of denture quality (patient, dentist): Esthetic and stability evaluation using Visual Analog Scale (VAS) (4) Evaluation of oral-related quality of life: Evaluation using Oral Health Impact Profile (OHIP) (5) Evaluation of masticatory function: glucose elution from gummy jelly chewing, occlusal force, occlusal contact area

Contacts

Public ContactTakashi Matsumoto

Department of Prosthodontics, Showa University Dental Hospital

matsutomo@dent.showa-u.ac.jp+81-3-3787-1151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026