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NCT Number: NCT06529900

The Effects of Technological Oral Health Management

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.

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Key information

Conditions

Oral Health Atrophy Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Malnutrition Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Sarcopenia Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Expected Results：

  • 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.
  • Provide teaching programs tailored to the evidence-based and individualized needs of the elderly.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

oral mastication training

Behavioral

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

texture and diet education

Behavioral

Teach the knowledge and techniques of softening food textures.

Primary outcomes

  1. Oral Frailty Index-8

    Time frame: 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.

  2. Iowa Oral Performance Instrument

    Time frame: Baseline, 1 month, 6 months.

    It is considered abnormal for values below the 5th percentile.

  3. Food Intake Questionnaire

    Time frame: 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.

  4. Comfort Eating Scale

    Time frame: 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).

  5. Mini Nutritional Assessment-Short Form

    Time frame: Baseline, 1 month, 6 months.

    0 - 7 points: malnourished; 8 - 11 points: at risk of malnutrition; or 12 - 14 points: well-nourished.

  6. Study of Osteoporotic Fracture

    Time frame: Baseline, 1 month, 6 months.

    One component was considered to be in a pre-frailty state, while two or more components indicated frailty.

  7. Handgrip strength

    Time frame: Baseline, 1 month, 6 months.

    Weak hand grip strength was defined as < 26 kg for men and < 18 kg for women.

Sponsors and collaborators

Lead sponsor

Chang Gung University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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