The Effects of Technological Oral Health Management

Not Applicable

Not yet recruiting

• Conditions: Malnutrition; Oral Health; Dysphagia; Sarcopenia
• Interventions: Behavioral: texture and diet education; Behavioral: oral mastication training

• Registration Number: NCT06529900
• Lead Sponsor: Chang Gung University of Science and Technology

Brief Summary

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.

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Study Start: 2024-09-02
• Primary Completion: 2025-05-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Texture and Diet Education	texture and diet education	Participants in this arm will receive texture and diet education without the oral mastication training component.
Oral Mastication Training and Texture and Diet Education	oral mastication training	Participants in this arm will receive oral mastication training combined with texture and diet education.
Oral Mastication Training and Texture and Diet Education	texture and diet education	Participants in this arm will receive oral mastication training combined with texture and diet education.

Primary Outcome Measures

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