Oral ManifestationsNCT05549648
The Oral Biomechanical Functions of Hong Kong Healthy Adults
A study testing Home oral excrise in people with Oral Manifestations, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Manifestations
- What is being tested?
- Home oral excrise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Faculty of Dentisry, the University of Hong Kong
Hong Kong, Hong Kong SAR, 000000
About this study
Official title: Artificial Intelligence-Based APP for Home Oral Muscles Exercises for Healthy Adults
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.
Read the detailed description
In 2020, this is not only a year of pandemic but also the year that the number of "super-aged" countries - where more than one in five of the population is 65 or older - reach to 13 including Japan, Germany, Italy, Netherlands, France, Sweden, Portugal, Slovenia and Croatia. By 2030, the number of countries would increase to 34 including Hong Kong, Korea, the US, the UK and New Zealand [1]. These countries are currently generating 80% of global GDP [2]. So, this 10-15% of super-aged global population is expected to create economic burden around 13-20% of GDP depending on the countries and policies [3], that will indeed severely affect global economy in the future if the ageing problem is not properly treated.
Hong Kong and Japan ranks number 1 and 2, respectively, lowest in 0-14 children population in the high income countries/region [2]. Facing to this low birth rate, according to the "Hong Kong Population Forecast 2020-2069", by 2069, the number of elderly people aged 65 or over in Hong Kong will reach 2.6 million, accounting for about 35.9% of the total population. The labor force between the ages of 15 and 64 will shrink to 3.9 million, accounting for 54.6% of the population [4].
In particular to dentistry, maintaining the oral function in elderly is very important, due to:
- food nutrients - when you eat you can obtain the nutrients from food, this provides you the essential energy for daily life. Loss of teeth or misfit of artificial teeth positively correlated with the risk of development in general chronic diseases [5].
- self-esteem - oral appearance and communication are significant factors contributing to elderly's psychological well-being and social life, impacting to the oral health related quality of life (OHRQoL) [6].
- neurological disorder - oral health was shown to related with strokes [7] and Alzheimer's disease [8] due to the invasion of oral bacteria such as Aggregatibacter actinomycetemcomitans, Prevotella intermedia, and Porphyromonas gingivalis. Only these two neurological disorders have accounted 0.08-0.52% loss of GDP in 47 prefectures in Japan in 2012, and the GDP lost is forecasted to be increasing continuously [9]. Tooth lost is a key factor.
Apparently, oral health is important to have healthy aging. The dental personnel play a key role in oral health, in terms of prevention, intervention, and education. In particular, prevention and education are comparatively low-cost strategies while intervention bears the higher cost, as shown in our previous study that countries/regions with better economic status had fewer severe impacts on diet-related aspects of OHRQoL [10]. Besides, our study also showed social and physiological factors "trouble pronouncing words" ranks significantly high similarly as other dietary factors, i.e., "uncomfortable to eat", "diet unsatisfactory" and "interrupt meals" among the developed countries with high economy. Indeed, the loss of teeth, new dental prostheses, and oral muscle dysfunction due to aging are the major contributing factors of pronunciation trouble. This physiological "oral frailty" declines the elder's mental and social health, and should be identified and addressed before the need for long-term care [11].
Utilizing technology to understand this situation deemed possible and "Age-tech" becomes an essential part of health technologies which means applying technology to identify, improve and treat oral frailty situations. The technology can also be useful to monitor and evaluate the efficiency of oral health conditions during this pandemic when the patients have limited mobility around the society.
- Conditions
- Oral Manifestations
- Being tested
- Home oral excrise
- Keywords
- oral frailty, oral muscle, home oral exercise
- Medical subject headings
- Oral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home oral excriseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Self-controlled Study | Other | Hong Kong citizens over 50 years old Receives: Other: Home oral excrise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
- Rinse mouth for 3 times, 20s at least for each time.
- Insert the test stick into GS-2, power on, and wait 6 seconds.
- Chewing for 20s, use the preferred chewing side.
- Rinse mouth with 10ml pure water and spit into the paper cup with a blue filter.
- 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: The 1, 30, 90, and 120 days after recruitment.
Secondary outcomes (2)
Swallowing function assessment
This was assessed using a questionnaire with EAT-10 and DRACE indicators that can detect the initial risks of dysphagia. A Chinese version of Eat-10, a self-reported outcome instrument on swallowing function, consisted of 10 questions on a 5-point Likert scale, with a minimum of 0 points and a maximum of 40 points. Physical symptoms of chewing and swallowing disorders were assessed via the Dysphagia Risk Assessment of the Community-dwelling elderly persons (DRACE) questionnaire. DRACE, which was translated by the research team, included 12 variables involving chewing, swallowing, coughing problems, etc., based on a 3-level scale from 0 (never occurs) to 2 (occurs frequently), with a minimum of 0 points and a maximum of 24 points. For both questionnaires, higher scores represent poorer swallowing function.
Measured: 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
Oral diadochokinesis (DDK) performance developed by HKU specifically in Cantonese or English (depends on participants' mother tongue) will be used. Participants will be instructed to repeat /pa/, /ta/, /ka/ as accurately and as quickly as the participants could within 10s respectively, and /pataka/ within 15s, at their normal speaking loudness level, speech recordings will be analyzed by speech therapist for speech motor assessment.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Aug 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Oral ManifestationsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kit Hon Tsoi, PhD, Principal investigator, Faculty of Dentistry, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549648
- Sponsor's protocol ID
- UW21-324
- Status last verified
- Aug 2022
- First submitted
- 13 Jul 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Johnston, L. What fast-ageing countries such as china tell us about our economic future. CommonWealth Magazine 2019.
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.
Hong kong population projections 2020-2069. The Government of HKSAR: Hong Kong, 2020.
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.
PubMed 22437676Nitschke 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.
PubMed 15646585Pillai 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.
PubMed 29402871Dominy 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.
PubMed 30746447Taghizadeh-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.
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.
Miura, H.; Tano, T. Recent measures in geriatric oral health care in japan. J. Natl. Inst. Public Health 2019, 68, 8-16.
O'Connor, S. (2014). World will have 13 'super-aged'nations by 2020. Financial Times, 11.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Based APP for Home Oral Muscles Exercises for Healthy Adults
- ClinicalTrials.gov ID
- NCT05549648
- Acronym / sponsor ID
- UW21-324
- Conditions
- Oral Manifestations
- Keywords
- oral frailty, oral muscle, home oral exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 22 Sep 2022 (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.
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.
Detailed description
In 2020, this is not only a year of pandemic but also the year that the number of "super-aged" countries - where more than one in five of the population is 65 or older - reach to 13 including Japan, Germany, Italy, Netherlands, France, Sweden, Portugal, Slovenia and Croatia. By 2030, the number of countries would increase to 34 including Hong Kong, Korea, the US, the UK and New Zealand [1]. These countries are currently generating 80% of global GDP [2]. So, this 10-15% of super-aged global population is expected to create economic burden around 13-20% of GDP depending on the countries and policies [3], that will indeed severely affect global economy in the future if the ageing problem is not properly treated.
Hong Kong and Japan ranks number 1 and 2, respectively, lowest in 0-14 children population in the high income countries/region [2]. Facing to this low birth rate, according to the "Hong Kong Population Forecast 2020-2069", by 2069, the number of elderly people aged 65 or over in Hong Kong will reach 2.6 million, accounting for about 35.9% of the total population. The labor force between the ages of 15 and 64 will shrink to 3.9 million, accounting for 54.6% of the population [4].
In particular to dentistry, maintaining the oral function in elderly is very important, due to:
- food nutrients - when you eat you can obtain the nutrients from food, this provides you the essential energy for daily life. Loss of teeth or misfit of artificial teeth positively correlated with the risk of development in general chronic diseases [5].
- self-esteem - oral appearance and communication are significant factors contributing to elderly's psychological well-being and social life, impacting to the oral health related quality of life (OHRQoL) [6].
- neurological disorder - oral health was shown to related with strokes [7] and Alzheimer's disease [8] due to the invasion of oral bacteria such as Aggregatibacter actinomycetemcomitans, Prevotella intermedia, and Porphyromonas gingivalis. Only these two neurological disorders have accounted 0.08-0.52% loss of GDP in 47 prefectures in Japan in 2012, and the GDP lost is forecasted to be increasing continuously [9]. Tooth lost is a key factor.
Apparently, oral health is important to have healthy aging. The dental personnel play a key role in oral health, in terms of prevention, intervention, and education. In particular, prevention and education are comparatively low-cost strategies while intervention bears the higher cost, as shown in our previous study that countries/regions with better economic status had fewer severe impacts on diet-related aspects of OHRQoL [10]. Besides, our study also showed social and physiological factors "trouble pronouncing words" ranks significantly high similarly as other dietary factors, i.e., "uncomfortable to eat", "diet unsatisfactory" and "interrupt meals" among the developed countries with high economy. Indeed, the loss of teeth, new dental prostheses, and oral muscle dysfunction due to aging are the major contributing factors of pronunciation trouble. This physiological "oral frailty" declines the elder's mental and social health, and should be identified and addressed before the need for long-term care [11].
Utilizing technology to understand this situation deemed possible and "Age-tech" becomes an essential part of health technologies which means applying technology to identify, improve and treat oral frailty situations. The technology can also be useful to monitor and evaluate the efficiency of oral health conditions during this pandemic when the patients have limited mobility around the society.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-controlled Study | Other | Other: Home oral excriseHong Kong citizens over 50 years old |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Home oral excriseThe 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 | Other | Self-controlled Study |
Primary outcome
Occlusal force assessment
Time frame: 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.
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).
Masticatory efficiency
Time frame: 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.
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.
Tongue function assessment
Time frame: 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.
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.
Dry mouth
Time frame: The 1, 30, 90, and 120 days after recruitment.
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
Oral health-related quality of life
Time frame: The 1, 30, 90, and 120 days after recruitment.
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.
2 secondary outcomes
Swallowing function assessment
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- BackgroundJohnston, L. What fast-ageing countries such as china tell us about our economic future. CommonWealth Magazine 2019.
- BackgroundLibicki, 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.
- BackgroundHong kong population projections 2020-2069. The Government of HKSAR: Hong Kong, 2020.
- Background: PubMed 22437676Rodrigues 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.
- Background: PubMed 15646585Nitschke 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.
- Background: PubMed 29402871Pillai 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.
- Background: PubMed 30746447Dominy 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.
- BackgroundTaghizadeh-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.
- BackgroundYon, 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.
- BackgroundMiura, H.; Tano, T. Recent measures in geriatric oral health care in japan. J. Natl. Inst. Public Health 2019, 68, 8-16.
- Results publicationO'Connor, S. (2014). World will have 13 'super-aged'nations by 2020. Financial Times, 11.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Kit Hon Tsoi, PhD principal investigator
Faculty of Dentistry, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home oral excrise in people with Oral Manifestations, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Oct 2023. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusal force assessment (time frame: 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.). The study lists 5 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 NCT05549648, which also lists 11 linked publications.
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 12 Oct 2023.