NCT05549648

Brief Summary

Hong Kong and Japan are similar in terms of facing the super-ageing society. Maintaining oral function in elderly is particularly important because it affects social, physical and mental health to the people and to the society. By using technology seems to be one of the solutions in dealing with this. Thus, this project aims at using state-of-the-art Age-tech that have been used in Japan to implement "Oral Frailty" concept in Hong Kong. Through identifying oral biomechanical in elderly population, the investigators expect the situation can be improved, and the data analysed and collected can be useful and impactful that can influence the dental communities around Southeast Asia and the globe.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

October 12, 2023

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

July 13, 2022

Last Update Submit

October 9, 2023

Conditions

Keywords

oral frailtyoral musclehome oral exercise

Outcome Measures

Primary Outcomes (5)

  • Occlusal force assessment

    The tooth models and occlusion will be taken to record the occlusal contact point, area and distribution, by intra-oral scanner (CEREC Omniscan / 3Shape), which is a standard practice at HKU. The occlusal force (N), occlusal contact area (mm2), maximum occlusal pressure (MPa), average occlusal pressure (MPa) of both sides are measured respectively, using occlusal pressure measurement film (Dental Prescale® II 50H, GC Corp) that is scanned with a dedicated scanner (GT-X830, Epson) with analysis software (Bite force analyzer, GC Corp).

    The 1, 30, 90, and 120 days after recruitment. The investigators wanted to see if exercise would help oral muscle performance, there's a lack of data on this, so the investigator couldn't determine a change over time.

  • Masticatory efficiency

    Gluco sensor (GS-II, GC Corp) will be used to quantitatively analyze the chewing ability 1. Rinse mouth for 3 times, 20s at least for each time. 2. Insert the test stick into GS-2, power on, and wait 6 seconds. 3. Chewing for 20s, use the preferred chewing side. 4. Rinse mouth with 10ml pure water and spit into the paper cup with a blue filter. 5. Discard the jelly residue in the filter, mix up the liquid (10s), dip the solution with a micro brush, point it on the test stick, wait for 6s for result reading, record reading: the concentration of sugar: \_\_\_\_mg/dL.

    The 1, 30, 90, and 120 days after recruitment. The investigators wanted to see if exercise would help oral muscle performance, there's a lack of data on this, so the investigator couldn't determine a change over time.

  • Tongue function assessment

    Tongue pressure sensor (TPM-02, GC Corp) which indicates the tongue physical function, will be used to record the maximum tongue pressure (MPa) for 3 times of each participant, then tongue endurance will also be measured for 3 times by determining how long tongue could sustain 60% of their maximal pressure.

    The 1, 30, 90, and 120 days after recruitment. The investigators wanted to see if exercise would help oral muscle performance, but there's a lack of data on improving this function, so the investigator couldn't determine a change over time.

  • Dry mouth

    A Chinese (Cantonese) version of dry mouth questionnaire consisting of 8-item xerostomia questions with a maximum total score of 32 points was used for subjective assessment, using a Likert format rated on a 4-point scale (1 not at all, 4 very much). Participants graded each aspect, with a higher score indicating impaired salivary function

    The 1, 30, 90, and 120 days after recruitment.

  • Oral health-related quality of life

    The Chinese-validated version of the Oral Health Impact Profile-14 (OHIP-14) questionnaire was used to assess oral health-related quality of life, using a Likert format rated on a 5-point scale (0 not at all, 4 very much) for 14 questions, higher scores represent the poorer oral condition-related quality of life, with a minimum 0 points and maximum 56 points.

    The 1, 30, 90, and 120 days after recruitment.

Secondary Outcomes (2)

  • Swallowing function assessment

    The 1, 30, 90, and 120 days after recruitment. The investigators wanted to see if exercise would help oral muscle performance, there's a lack of data on this, so the investigator couldn't determine a change over time.

  • DDK rate

    The 1, 30, 90, and 120 days after recruitment. The investigators wanted to see if exercise would help oral muscle performance, there's a lack of data on this, so the investigator couldn't determine a change over time.

Study Arms (1)

Self-controlled Study

OTHER

Hong Kong citizens over 50 years old

Other: Home oral excrise

Interventions

The current study aimed to evaluate the efficacy and user experience of mobile phone APP, a mobile application with AI component in facial movement tracking, in improving oral functions of elderly people

Self-controlled Study

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Population with aged (50-90 y.o.) neurologically healthy citizens in Hong Kong who have at least 1 occluding paired molars.
  • Can read Traditional Chinese and communicate in Cantonese
  • Possessed a smartphone with internet access and was able to use it on their own or with the help of at least one family member
  • passed the Montreal Cognitive Assessment 5-Minute Protocol (Hong Kong Version)

You may not qualify if:

  • Subject who was under 50 or unable to give consent.
  • Subject who has Cerebrovascular accident, Head and Neck Cancers, Neurologic Diseases, and other severe systemic diseases.
  • Subject who is receiving radiotherapy and chemotherapy.
  • Subject who was medically unfit.
  • Subject who has no molar.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentisry, the University of Hong Kong

Hong Kong, Hong Kong SAR, 000000, Hong Kong

Location

Related Publications (11)

  • Johnston, L. What fast-ageing countries such as china tell us about our economic future. CommonWealth Magazine 2019.

    BACKGROUND
  • Libicki, M.C.; Shatz, H.J.; Taylor, J.E. The economic burden of aging populations. In Global demographic change and its implications for military power, RAND Corporation: 2011; pp 59-82.

    BACKGROUND
  • Hong kong population projections 2020-2069. The Government of HKSAR: Hong Kong, 2020.

    BACKGROUND
  • Rodrigues HL Jr, Scelza MF, Boaventura GT, Custodio SM, Moreira EA, Oliveira Dde L. Relation between oral health and nutritional condition in the elderly. J Appl Oral Sci. 2012 Feb;20(1):38-44. doi: 10.1590/s1678-77572012000100008.

    PMID: 22437676BACKGROUND
  • Nitschke I, Muller F. The impact of oral health on the quality of life in the elderly. Oral Health Prev Dent. 2004;2 Suppl 1:271-5.

    PMID: 15646585BACKGROUND
  • Pillai RS, Iyer K, Spin-Neto R, Kothari SF, Nielsen JF, Kothari M. Oral Health and Brain Injury: Causal or Casual Relation? Cerebrovasc Dis Extra. 2018;8(1):1-15. doi: 10.1159/000484989. Epub 2018 Jan 9.

    PMID: 29402871BACKGROUND
  • Dominy SS, Lynch C, Ermini F, Benedyk M, Marczyk A, Konradi A, Nguyen M, Haditsch U, Raha D, Griffin C, Holsinger LJ, Arastu-Kapur S, Kaba S, Lee A, Ryder MI, Potempa B, Mydel P, Hellvard A, Adamowicz K, Hasturk H, Walker GD, Reynolds EC, Faull RLM, Curtis MA, Dragunow M, Potempa J. Porphyromonas gingivalis in Alzheimer's disease brains: Evidence for disease causation and treatment with small-molecule inhibitors. Sci Adv. 2019 Jan 23;5(1):eaau3333. doi: 10.1126/sciadv.aau3333. eCollection 2019 Jan.

    PMID: 30746447BACKGROUND
  • Taghizadeh-Hesary, F.; Yoshino, N.; Mortha, A.; Taghizadeh-Hesary, F.; Roshanmehr, F.; Fiallos, J.; Tajra, E.; Bolanos, J.; Amaya, M.; Dang, J., et al. Economic burden of neurological disorders in an aging society (japan): A panel data analysis. . In ADBI Working Paper 1092, Asian Development Bank Institute: Tokyo, 2020.

    BACKGROUND
  • Yon, M.J.Y.; Lam, Y.H.W.; Tsoi, K.H. Do economic and dental resources affect older persons' ohrqol? In IADR/PER 96th General Session & Exhibition, International Association for Dental Research. The Abstract's web site is located at http://www.iadr.org/: United States, 2018; Vol. 97, p no. 3003.

    BACKGROUND
  • Miura, H.; Tano, T. Recent measures in geriatric oral health care in japan. J. Natl. Inst. Public Health 2019, 68, 8-16.

    BACKGROUND
  • O'Connor, S. (2014). World will have 13 'super-aged'nations by 2020. Financial Times, 11.

    RESULT

MeSH Terms

Conditions

Oral Manifestations

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kit Hon Tsoi, PhD

    Faculty of Dentistry, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2022

First Posted

September 22, 2022

Study Start

August 1, 2022

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

October 12, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Deidentified participant data, study protocol, statistical analysis methods, and informed consent form can be requested after research is published from the principal investigator (jkhtsoi@hku.hk) who will coordinate with the study senior centers and hospital to ensure that any data sharing complies with the General Data Protection Regulations, the Hong Kong Personal Data (Privacy) Ordinance, and other legal agreements.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
the data will be available after the results are released and published.
Access Criteria
requested from the principal investigator via email: jkhtsoi@hku.hk

Locations