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临床试验/NCT05046210
NCT05046210已完成不适用

Oral Exercise With Lay Health Advisor Strategy on Oral Self-care Behaviors, Oral Hygiene, Oral Function and Quality of Life Among Older Adults in Aboriginal Communities in Taiwan: A Randomized Controlled Trial

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年9月10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
240
试验地点
1
主要终点
Oral health-related quality of life

研究概览

简要总结

In the present study, the investigators aimed to evaluate the effectiveness of community-based oral exercise with LHA intervention on the oral health-related quality of life, oral function and oral self-care behaviors. This randomized controlled trial included LHA group (EG) and leaflet group (CG), respectively. The EG received a four-week one-on-one session by an LHA. Baseline and follow-up data collection were used to collect the data in oral Self-care behaviors, oral hygiene, oral function and quality of life.

详细描述

A randomized controlled trial (RCT) was conducted. The participants recruited from aboriginal communities in Eastern Taiwan. Data collecting time was from 2019 to 2020. Participants from the identified communities were randomly assigned to EG or CG using random table. Participants who were 55 years old or above and indigenous people were recruited in the study. Participants who were disability, have had oral cancer, impaired facial appearance and impaired cognitive function were excluded. Impaired cognitive function was screening by Short Portable Mental Status Questionnaire (SPMSQ). Participants were recruited according to the predetermined minimal sample size estimated based on a type I error = 0.05, power = 0.95, and effect size (ES) f = 0.25 (medium effect in Cohen's f) . The number of samples in each group was expected 66 participants. An additional 30% drop out rate was added. The final number of samples for each group were required at least 86 participants. The total sample size was 122 and 118 in EG and CG, respectively. All participants underwent data collection at baseline and at 2-week, 3-and 6-month follow-ups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Participants from the identified communities were randomly assigned to experimental group or control group using random table.

入排标准

年龄范围
55 Years 至 82 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 55 years old or above and indigenous people

排除标准

  • Disability, have had oral cancer, impaired facial appearance and impaired cognitive function were excluded.
  • Impaired cognitive function was screening by Short Portable Mental Status Questionnaire (SPMSQ).

结局指标

主要结局

Oral health-related quality of life

时间窗: Change from baseline at 3-month and 6-month after intervention

OHRQoL was measured using the Geriatric Oral Health Assessment Index (GOHAI) , which was translated into Chinese for the participants (GOHAI-T). For example, "Are you satisfied or happy with the appearance of your teeth, gums or dentures?" Possible responses were range from 1 (always) to 5 (never). The total score ranged from 12 to 60 points. The higher the score, the better the quality of life. Cronbach's alpha was 0.75 for the scale.

Swallowing

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

The Repetitive Saliva-Swallowing Test (RSST) was used to evaluate swallowing. Participants were asked to swallow saliva as many times as possible in 30 seconds.

syllable /pa/, /ta/ and /ka/

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

For oral diadochokinesis (DDK), the participants were asked to repeat the /pa/, /ta/, and /ka/ syllables as quickly as possible, and the number of articulations was counted. Using a digital counter, we separately counted the number of articulations of the /pa/, /ta/, and /ka/ syllables within 10 seconds.

Masticatory performance

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

Masticatory performance was evaluated using the color-changeable chewing gum (Xylitol, 3.0 g Lotte, Saitama, Japan). This chewing gum contains xylitol, citric acid, and red, yellow, and blue dyes that change color when subjected to masticatory forces from chewing. The red dye is pH sensitive and changes color under neutral or alkaline conditions. Citric acid maintains a low internal pH of the yellowish-green gum before chewing commences. The gum changes to red when chewed because the yellow and blue dyes seep into saliva, and citric acid elution produces the red color. Participants were asked to chew for 2 minutes. Two minutes later, the observer checked the color of the gum by using a color chart of five color gradations ranging from 1 (very poor) to 5 (very good).

Saliva flow rate

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

Saliva flow rate was measured the saliva flow rate in one minute (ml/min). Participants were asked to chew the gauze for two minutes and spited out the gauze and saliva back into the test tube. After centrifuging the saliva of the gauze, pour the saliva into a measuring tube to measure the volume of the saliva.

Perceived dysphagia

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

Perceived dysphagia, which was defined as a subjective perception of problems swallowing, was measured using the swallowing screening scale developed by Ohkuma and has an internal consistency Cronbachα's alpha coefficient of 0.85. Examples of questions included "Do you ever have difficulty swallowing?" "Do you ever have difficulty as a result of cough up phlegm during or after a meal?" "Does it take you longer to eat a meal than it used to?" "Do you feel that it is becoming difficult to eat solid foods?" and "Do you ever have difficulty sleeping because of coughing during the night?" Possible responses were "obviously" (frequently), "slightly" (sometimes), or "no" (never). Respondents with at least one severe symptom were classified as having dysphagia.

Plaque control record (PCR)

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

Plaque control record (PCR) was measured the percentage of tooth surface with plaque. PCR range from 0 to 100%.

Plaque index (PI)

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

Plaque index (PI) was measured the six indicator teeth 12, 16, 24, 32, 36, 44 and the score for each tooth is range from 0 to 3 (0 = no plaque, 1 = a film of plaque adhering to the free gingival margin and adjacent area of the tooth, 2 = moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye, 3 = abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin). Then summing the average of 6 indicators teeth.

Winkel tongue coating index (WTCI)

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

Winkel tongue coating index (WTCI) was measured the accumulation of coating on the surface of the tongue. The tongue was divided into six areas (three posterior and three anterior), and the coating was scored as 0 = no coating, 1 = light coating, or 2 = severe coating; scores ranged from 0 to 12 points.

Regular dental visit

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

The question of dental visit, "Do you see a dentist every six months?" Possible responses were "Yes", "No".

Brushing ≥2 times/day

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

The question of tooth-brushing, "How many times do you brush your teeth a day?" Possible responses were "None", "One time", "Two times" and "More than 3 times".

Use of interdental brushes

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

The question of interdental brush, "Do you use an interdental brush every day?" Possible responses were "Yes", "No" and "Never heard".

Use of dental floss

时间窗: Change from baseline at 2-week, 3-month and 6-month after intervention

The question of flossing, "Do you use dental floss every day?" Possible responses were "Yes", "No" and "Never heard".

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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