Oral Dryness and Saliva AlteredNCT05938166
The Effects of Using Augmented Reality (AR) System to Train Foreign Care Workers.
A study testing oral care augmented reality (AR) and video-based oral hygiene education course in people with Oral Dryness and Saliva Altered and Oral Manifestations, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Dryness and Saliva Altered, Oral Manifestations, Swallowing Disorder
- What is being tested?
- oral care augmented reality (AR) and video-based oral hygiene education course
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. The Indonesian caregivers who are employed in Kaohsiung City are aged between 21 and 65 and have simple Chinese communication skills.
- 2. The elderly people being cared for is over 65 years old.
Who cannot join
- 1. Elderly people who are unable to cooperate with instructions.
- 2. Elderly people with facial impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University
Kaohsiung City, Sanmin Dist, 807
leu k hsun, Master, +886-7-3121101 ext. 2159, leu1026@gmail.com
About this study
Official title: The Effects of Using Augmented Reality (AR) System to Train Foreign Care on Salivary Biomarker and Oral Function of the Elderly People
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.
Read the detailed description
A randomized experimental design was used. Female foreign care workers whose aged 21 to 65 years and by cared older peoples whose aged 65 to 75 years were recruited through community-based site of long-term care service in Kaohsiung city. Each group was expected for 12 care workers and by cared older peoples who each group. G*Power (version 3.1.9.4) was used for power analysis.
All foreign care workers whose participants will underwent questionnaire examination at baseline and at 1-month, 3-month, 6-month follow-ups. The information of foreign care workers regarding oral care cognition, attitude, self-efficacy, and oral care behavior intention will be collected by a self-report questionnaire before and after intervention.
Each by cared older peoples will be evaluation oral hygiene and function by oral hygienist, and will completed the questionnaire at baseline and at 1-month, 3-month and 6-month follow-up. Older people by cared will assess plaque control record (PCR), tongue coating index (TCI), repetitive saliva swallowing test (RSST), oral diadochokinetic (DDK), oral moisture degree (OMD),masticatory efficiency (MoE) and salivary biomarker at baseline (Time 1), three months (Time 2) and six months (Time 3) follow-ups.
- Being tested
- oral care augmented reality (AR), video-based oral hygiene education course
- Keywords
- AR (augmented reality), Oral Care Behavior, Saliva Biomarker
- Medical subject headings
- Xerostomia, Oral Manifestations, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral care augmented reality (AR)Device
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.
video-based oral hygiene education courseOther
50-minute video-based oral hygiene education course
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: video-based oral hygiene education course |
| Control Group | No intervention | The CG only receive only a booklet of traditional classroom oral health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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:
- First times / Maximum Kpa value.
- Second times / Maximum Kpa value.
- Third times / Maximum Kpa value.
Average of maximum tongue pressure in 3 times.
Measured: 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:
- First times / Maximum Kpa value.
- Second times / Maximum Kpa value.
- Third times / Maximum Kpa value.
Average of maximum tongue pressure in 3 times.
Measured: 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:
- First times / Maximum Kpa value.
- Second times / Maximum Kpa value.
- Third times / Maximum Kpa value.
Average of maximum tongue pressure in 3 times.
Measured: 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 .
- light green: very poor chewing ability.
- light yellow: poor chewing ability.
- light pink: no good chewing ability.
- pink: good chewing ability.
- red: very good chewing ability.
Measured: 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 .
- light green: very poor chewing ability.
- light yellow: poor chewing ability.
- light pink: no good chewing ability.
- pink: good chewing ability.
- red: very good chewing ability.
Measured: 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 .
- light green: very poor chewing ability.
- light yellow: poor chewing ability.
- light pink: no good chewing ability.
- pink: good chewing ability.
- red: very good chewing ability.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
The GOHAI-T of 12 questions was assessment using self-assessment oral health questionnaire.
Have participants been totally unable to function" The scores ranged from one ("never") to five ("always"), with the total possible score ranging from 12 to 60.
Measured: Change from Baseline at 1 month after intervention
GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)
The GOHAI-Scale of 12 questions was assessment using self-assessment oral health questionnaire.
Have participants been totally unable to function" The scores ranged from one ("never") to five ("always"), with the total possible score ranging from 12 to 60.
Measured: Change from Baseline at 3 month after intervention
GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)
The GOHAI-Scale of 12 questions was assessment using self-assessment oral health questionnaire.
Have participants been totally unable to function" The scores ranged from one ("never") to five ("always"), with the total possible score ranging from 12 to 60.
Measured: Change from Baseline at 6 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start3 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Dryness and Saliva AlteredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938166
- Sponsor's protocol ID
- KMUHIRB-SV(II)-20230019
- Status last verified
- Mar 2025
- First submitted
- 3 Jul 2023
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 35207706
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using Augmented Reality (AR) System to Train Foreign Care on Salivary Biomarker and Oral Function of the Elderly People
- ClinicalTrials.gov ID
- NCT05938166
- Acronym / sponsor ID
- KMUHIRB-SV(II)-20230019
- Keywords
- AR (augmented reality), Oral Care Behavior, Saliva Biomarker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized experimental design was used. Female foreign care workers whose aged 21 to 65 years and by cared older peoples whose aged 65 to 75 years were recruited through community-based site of long-term care service in Kaohsiung city. Each group was expected for 12 care workers and by cared older peoples who each group. G*Power (version 3.1.9.4) was used for power analysis.
All foreign care workers whose participants will underwent questionnaire examination at baseline and at 1-month, 3-month, 6-month follow-ups. The information of foreign care workers regarding oral care cognition, attitude, self-efficacy, and oral care behavior intention will be collected by a self-report questionnaire before and after intervention.
Each by cared older peoples will be evaluation oral hygiene and function by oral hygienist, and will completed the questionnaire at baseline and at 1-month, 3-month and 6-month follow-up. Older people by cared will assess plaque control record (PCR), tongue coating index (TCI), repetitive saliva swallowing test (RSST), oral diadochokinetic (DDK), oral moisture degree (OMD),masticatory efficiency (MoE) and salivary biomarker at baseline (Time 1), three months (Time 2) and six months (Time 3) follow-ups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental group (EG-A) | Experimental | Device: oral care augmented reality (AR), Other: video-based oral hygiene education courseBehavioral: The experimental of A group received a 40-minute AR tooth-cleaning skills session and a 50-minute video-based oral hygiene education course. |
| experimental group (EG-B) | Experimental | Other: video-based oral hygiene education courseThe experimental of B group received a 50-minute video-based oral hygiene education course. |
| Control Group | No intervention | –The CG only receive only a booklet of traditional classroom oral health education |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. The Indonesian caregivers who are employed in Kaohsiung City are aged between 21 and 65 and have simple Chinese communication skills.
- 2. The elderly people being cared for is over 65 years old.
Key exclusion criteria (2 listed)
- 1. Elderly people who are unable to cooperate with instructions.
- 2. Elderly people with facial impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral care augmented reality (AR)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. | Device | experimental group (EG-A) |
| video-based oral hygiene education course50-minute video-based oral hygiene education course | Other | experimental group (EG-A), experimental group (EG-B) |
Primary outcome
Tongue Coating Index(TCI)
Time frame: Change from Baseline TCI at 1-month after intervention
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
Tongue Coating Index(TCI)
Time frame: Change from Baseline TCI at 3-month after intervention
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
Tongue Coating Index(TCI)
Time frame: Change from Baseline TCI at 6-month after intervention
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
Oral Dryness Status
Time frame: Change from Baseline Oral Dryness Status at 1-month after intervention
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.
Oral Dryness Status
Time frame: Change from Baseline Oral Dryness Status at 3-month after intervention
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.
Oral Dryness Status
Time frame: Change from Baseline Oral Dryness Status at 6-month after intervention
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.
Lip-Tongue Motor Function
Time frame: Change from Baseline lip-tongue motor function Status at 1-month after intervention
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
Lip-Tongue Motor Function
Time frame: Change from Baseline lip-tongue motor function Status at 3-month after intervention
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
Lip-Tongue Motor Function
Time frame: Change from Baseline lip-tongue motor function Status at 6-month after intervention
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
Maximum tongue pressure (MTP)
Time frame: Change from Baseline Maximum tongue pressure status at 1-month after intervention
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.
Maximum tongue pressure (MTP)
Time frame: Change from Baseline Maximum tongue pressure status at 2-month after intervention
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.
Maximum tongue pressure (MTP)
Time frame: Change from Baseline Maximum tongue pressure status at 3-month after intervention
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.
Masticatory Function
Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention status at 3-month after intervention
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.
Masticatory Function
Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention status at 3-month after intervention
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.
Masticatory Function
Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention status at 3-month after intervention
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.
Saliva Swallowing Test(RSST)
Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention
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.
Saliva Swallowing Test(RSST)
Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention
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.
Saliva Swallowing Test(RSST)
Time frame: Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention
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.
3 secondary outcomes
GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)
Time frame: Change from Baseline at 1 month after intervention
GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)
Time frame: Change from Baseline at 3 month after intervention
GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)
Time frame: Change from Baseline at 6 month after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Results publication: PubMed 35207706Chang 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral care augmented reality (AR) and video-based oral hygiene education course in people with Oral Dryness and Saliva Altered and Oral Manifestations, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact leu k hsun, Master (+886-7-3121101 ext. 2159, leu1026@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tongue Coating Index(TCI) (time frame: Change from Baseline TCI at 1-month after intervention). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05938166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.