NCT05938166

Brief Summary

The aim of this study was to evaluate the effect of augmented reality (AR) system training intervention of foreign care workers on the salivary biomarker and oral function of older people. This randomized controlled trial included experimental group: AR group (EG-A) Video group (EG-B) and control group(CG), respectively. The EG-A will receive augmented reality (AR) system training intervention with AR tooth-cleaning skills session course add video-based oral hygiene education course . The EG-B receive video-based oral hygiene education course and The CG only receive only a leaflet.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jan 2024Dec 2026

First Submitted

Initial submission to the registry

July 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

January 3, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

July 3, 2023

Last Update Submit

March 4, 2025

Conditions

Keywords

AR (augmented reality)Oral Care BehaviorSaliva Biomarker

Outcome Measures

Primary Outcomes (18)

  • Tongue Coating Index(TCI)

    The tongue-coating status of 9 areas of tongue surfaces was recorded using the tongue coating index, as follows: Score 0: Tongue coating not visible. Score 1: Tongue coating thin, papillae of tongue visible. Score 2: Tongue coating very thick, papillae of tongue not visible. Range= 0 to 18 Score

    Change from Baseline TCI at 1-month after intervention

  • Tongue Coating Index(TCI)

    The tongue-coating status of 9 areas of tongue surfaces was recorded using the tongue coating index, as follows: Score 0: Tongue coating not visible. Score 1: Tongue coating thin, papillae of tongue visible. Score 2: Tongue coating very thick, papillae of tongue not visible. Range= 0 to 18 Score

    Change from Baseline TCI at 3-month after intervention

  • Tongue Coating Index(TCI)

    The tongue-coating status of 9 areas of tongue surfaces was recorded using the tongue coating index, as follows: Score 0: Tongue coating not visible. Score 1: Tongue coating thin, papillae of tongue visible. Score 2: Tongue coating very thick, papillae of tongue not visible. Range= 0 to 18 Score

    Change from Baseline TCI at 6-month after intervention

  • Oral Dryness Status

    The oral dryness status of saliva flow rate was recorded using the saxon test(Chew gauze sponge for 2 mins), as follows: Normal: 2.75 g/2min. Oral dryness: 2 g/2min.

    Change from Baseline Oral Dryness Status at 1-month after intervention

  • Oral Dryness Status

    The oral dryness status of saliva flow rate was recorded using the saxon test(Chew gauze sponge for 2 mins), as follows: Normal: 2.75 g/2min. Oral dryness: 2 g/2min.

    Change from Baseline Oral Dryness Status at 3-month after intervention

  • Oral Dryness Status

    The oral dryness status of saliva flow rate was recorded using the saxon test(Chew gauze sponge for 2 mins), as follows: Normal: 2.75 g/2min. Oral dryness: 2 g/2min.

    Change from Baseline Oral Dryness Status at 6-month after intervention

  • Lip-Tongue Motor Function

    The lip-tongue motor function status of count-by-time was recorded using the Oral diadochokinesis rate (lip-tongue function (Pa/ Ta /Ka) in syllables or times per 15 seconds), as follows: Pa:times/ per 15 seconds Ta:times /per 15 seconds Ka:times /per 15 seconds

    Change from Baseline lip-tongue motor function Status at 1-month after intervention

  • Lip-Tongue Motor Function

    The lip-tongue motor function status of count-by-time was recorded using the Oral diadochokinesis rate (lip-tongue function (Pa/ Ta /Ka) in syllables or times per 15 seconds), as follows: Pa:times/ per 15 seconds Ta:times /per 15 seconds Ka:times /per 15 seconds

    Change from Baseline lip-tongue motor function Status at 3-month after intervention

  • Lip-Tongue Motor Function

    The lip-tongue motor function status of count-by-time was recorded using the Oral diadochokinesis rate (lip-tongue function (Pa/ Ta /Ka) in syllables or times per 15 seconds), as follows: Pa:times/ per 15 seconds Ta:times /per 15 seconds Ka:times /per 15 seconds

    Change from Baseline lip-tongue motor function Status at 6-month after intervention

  • Maximum tongue pressure (MTP)

    The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: 1. First times / Maximum Kpa value. 2. Second times / Maximum Kpa value. 3. Third times / Maximum Kpa value. Average of maximum tongue pressure in 3 times.

    Change from Baseline Maximum tongue pressure status at 1-month after intervention

  • Maximum tongue pressure (MTP)

    The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: 1. First times / Maximum Kpa value. 2. Second times / Maximum Kpa value. 3. Third times / Maximum Kpa value. Average of maximum tongue pressure in 3 times.

    Change from Baseline Maximum tongue pressure status at 2-month after intervention

  • Maximum tongue pressure (MTP)

    The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: 1. First times / Maximum Kpa value. 2. Second times / Maximum Kpa value. 3. Third times / Maximum Kpa value. Average of maximum tongue pressure in 3 times.

    Change from Baseline Maximum tongue pressure status at 3-month after intervention

  • Masticatory Function

    The mixing ability was assessed using color-changeable chewing gum (Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan) , as follows: To chew as usual on the gum 120 seconds. The chewing rhythm was kept constant at once per second.color scale consisting of five intermediate colors . 1. light green: very poor chewing ability. 2. light yellow: poor chewing ability. 3. light pink: no good chewing ability. 4. pink: good chewing ability. 5. red: very good chewing ability.

    Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention status at 3-month after intervention

  • Masticatory Function

    The mixing ability was assessed using color-changeable chewing gum (Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan) , as follows: To chew as usual on the gum 120 seconds. The chewing rhythm was kept constant at once per second.color scale consisting of five intermediate colors . 1. light green: very poor chewing ability. 2. light yellow: poor chewing ability. 3. light pink: no good chewing ability. 4. pink: good chewing ability. 5. red: very good chewing ability.

    Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention status at 3-month after intervention

  • Masticatory Function

    The mixing ability was assessed using color-changeable chewing gum (Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan) , as follows: To chew as usual on the gum 120 seconds. The chewing rhythm was kept constant at once per second.color scale consisting of five intermediate colors . 1. light green: very poor chewing ability. 2. light yellow: poor chewing ability. 3. light pink: no good chewing ability. 4. pink: good chewing ability. 5. red: very good chewing ability.

    Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention status at 3-month after intervention

  • Saliva Swallowing Test(RSST)

    The swallowing function states of times complete swallowing within 30 seconds was recorded using the Saliva Swallowing Test(RSST), as follows: participation was asked to swallow saliva as many times as possible for 30 s, while deglutition is counted through palpation of the larynx.

    Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention

  • Saliva Swallowing Test(RSST)

    The swallowing function states of times complete swallowing within 30 seconds was recorded using the Saliva Swallowing Test(RSST), as follows: participation was asked to swallow saliva as many times as possible for 30 s, while deglutition is counted through palpation of the larynx.

    Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention

  • Saliva Swallowing Test(RSST)

    The swallowing function states of times complete swallowing within 30 seconds was recorded using the Saliva Swallowing Test(RSST), as follows: participation was asked to swallow saliva as many times as possible for 30 s, while deglutition is counted through palpation of the larynx.

    Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention

Secondary Outcomes (3)

  • GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)

    Change from Baseline at 1 month after intervention

  • GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)

    Change from Baseline at 3 month after intervention

  • GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)

    Change from Baseline at 6 month after intervention

Study Arms (3)

experimental group (EG-A)

EXPERIMENTAL

Behavioral: The experimental of A group received a 40-minute AR tooth-cleaning skills session and a 50-minute video-based oral hygiene education course.

Device: oral care augmented reality (AR)Other: video-based oral hygiene education course

experimental group (EG-B)

EXPERIMENTAL

The experimental of B group received a 50-minute video-based oral hygiene education course.

Other: video-based oral hygiene education course

Control Group

NO INTERVENTION

The CG only receive only a booklet of traditional classroom oral health education

Interventions

Augmented reality (AR) is an extension of perceptible reality, whereby additional information, such as texts or virtual objects, can be displayed in the user's field of vision.The oral care augmented reality (AR) simulation training can train foreign care workers by switching languages (Indonesian) and therefore reduce language-related learning barriers.

experimental group (EG-A)

50-minute video-based oral hygiene education course

experimental group (EG-A)experimental group (EG-B)

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. The Indonesian caregivers who are employed in Kaohsiung City are aged between 21 and 65 and have simple Chinese communication skills.
  • \. The elderly people being cared for is over 65 years old.

You may not qualify if:

  • \. Elderly people who are unable to cooperate with instructions.
  • \. Elderly people with facial impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Sanmin Dist, 807, Taiwan

RECRUITING

Related Publications (1)

  • Chang AH, Lin PC, Lin PC, Lin YC, Kabasawa Y, Lin CY, Huang HL. Effectiveness of Virtual Reality-Based Training on Oral Healthcare for Disabled Elderly Persons: A Randomized Controlled Trial. J Pers Med. 2022 Feb 4;12(2):218. doi: 10.3390/jpm12020218.

    PMID: 35207706BACKGROUND

MeSH Terms

Conditions

XerostomiaOral ManifestationsDeglutition Disorders

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

leu k hsun, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 10, 2023

Study Start

January 3, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations