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临床试验/NCT05549648
NCT05549648已完成不适用

Artificial Intelligence-Based APP for Home Oral Muscles Exercises for Healthy Adults

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
2
主要终点
Tongue function assessment

研究概览

简要总结

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.

详细描述

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:

  1. 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].
  2. 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].
  3. 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].

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

结局指标

主要结局

Tongue function assessment

时间窗: 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

时间窗: 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

Occlusal force assessment

时间窗: 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

时间窗: 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.

Oral health-related quality of life

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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