The Effects of Technological Oral Health Management

NCT06529900 | Not Yet Recruiting

• 1 other identifier: 111-670
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Health; Malnutrition; Dysphagia; Sarcopenia

Keywords

the elderly in the community; oral health; nutrition; eating ability; physical function; technological oral health management; dentures

Outcome Measures

Primary Outcomes (7)

• 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.

Study Arms (2)

Oral Mastication Training and Texture and Diet Education

EXPERIMENTAL

Participants in this arm will receive oral mastication training combined with texture and diet education.

Behavioral: oral mastication training; Behavioral: texture and diet education

Texture and Diet Education

ACTIVE COMPARATOR

Participants in this arm will receive texture and diet education without the oral mastication training component.

Behavioral: texture and diet education

Interventions

oral mastication training BEHAVIORAL

Through specific exercises and techniques aimed at enhancing masticatory function and overall oral health.

Oral Mastication Training and Texture and Diet Education

texture and diet education BEHAVIORAL

Teach the knowledge and techniques of softening food textures.

Oral Mastication Training and Texture and Diet Education; Texture and Diet Education

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• non-residents of Chiayi County
• unable to take care of themselves or are unconscious
• demented or mentally challenged and are unable to cooperate

Sponsors & Collaborators

• Chang Gung University of Science and Technology: lead

MeSH Terms

Conditions

Malnutrition; Deglutition Disorders; Sarcopenia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 31, 2024
• Study Start: September 2, 2024
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07