The Effects of Technological Oral Health Management

The Effects of Technological Oral Health Management on Improving Oral Health, Eating Ability, Nutritional Status, and Physical Function of the Elderly in the Community After Wearing Removable Dentures: An Example of the Agricultural County

The goal of interventional study is to for the elderly who have poor chewing and eating ability after installing removable dentures through the intervention of oral mastication training and texture and diet education, the effects on oral health, eating ability, nutrition, and physical function changes are confirmed in Elderly individuals residing in Chiayi County who are 65 years of age or older, capable of self-care, conscious, and able to communicate in Mandarin and Taiwanese. The main question it aims to answer is:

•Are there significant benefits to oral health, eating ability, nutrition, and physical function through the intervention of oral mastication training and texture and diet education? Researchers will compare changes in oral health, eating ability, nutrition, and physical functioning results to see if oral mastication training is effective.

Participants will:

• Experimental group: oral mastication training and texture and diet education.
• Control group: only texture and diet education.
• Cases were tracked in month 1 and will be tracked again in month 6.

Study Overview

• Status: Not yet recruiting
• Conditions: Malnutrition; Sarcopenia; Dysphagia; Oral Health
• Intervention / Treatment: Behavioral: oral mastication training; Behavioral: texture and diet education

Detailed Description

Expected Results：

1. To establish an oral mastication training and texture and diet education program for the elderly who have poor chewing and eating ability after dentures are installed.
2. Provide teaching programs tailored to the evidence-based and individualized needs of the elderly.
3. Through the implementation of evidence-based oral mastication training and a texture and diet education program, the experimental group and the control group are expected to show variations in oral health, eating ability, nutrition, and physical function over time.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. residing in Chiayi County who are 65 years of age or older
2. capable of self-care, conscious
3. able to communicate in Mandarin and Taiwanese.

Exclusion Criteria:

1. non-residents of Chiayi County
2. unable to take care of themselves or are unconscious
3. demented or mentally challenged and are unable to cooperate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Mastication Training and Texture and Diet Education; Participants in this arm will receive oral mastication training combined with texture and diet education.	Behavioral: oral mastication training; Through specific exercises and techniques aimed at enhancing masticatory function and overall oral health.; Behavioral: texture and diet education; Teach the knowledge and techniques of softening food textures.
Active Comparator: Texture and Diet Education; Participants in this arm will receive texture and diet education without the oral mastication training component.	Behavioral: texture and diet education; Teach the knowledge and techniques of softening food textures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Frailty Index-8	The total score was 11 points. 0-2 points: low risk, 3 points: medium risk, and 4 points or above: high risk.	Baseline, 1 month, 6 months.
Iowa Oral Performance Instrument	It is considered abnormal for values below the 5th percentile.	Baseline, 1 month, 6 months.
Food Intake Questionnaire	A subject with four or more 'difficult-to-eat' responses to the 14-food group questionnaire would be classified as abnormal.	Baseline, 1 month, 6 months.
Comfort Eating Scale	On a scale of 1 to 10, where 1 represents very good (no impact, no pain) and 10 represents very bad (impact, pain).	Baseline, 1 month, 6 months.
Mini Nutritional Assessment-Short Form	0 - 7 points: malnourished; 8 - 11 points: at risk of malnutrition; or 12 - 14 points: well-nourished.	Baseline, 1 month, 6 months.
Study of Osteoporotic Fracture	One component was considered to be in a pre-frailty state, while two or more components indicated frailty.	Baseline, 1 month, 6 months.
Handgrip strength	Weak hand grip strength was defined as < 26 kg for men and < 18 kg for women.	Baseline, 1 month, 6 months.

Collaborators and Investigators

• Sponsor: Chang Gung University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): September 2, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: nutrition; physical function; oral health; the elderly in the community; eating ability; technological oral health management; dentures
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Nutrition Disorders; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Malnutrition
• Other Study ID Numbers: 111-670

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No