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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034503
Receipt No. R000037672
Scientific Title A randomized controlled trial using digital device providing visualized brushing instruction
Date of disclosure of the study information 2018/10/20
Last modified on 2020/07/25

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Basic information
Public title A randomized controlled trial using digital device providing visualized brushing instruction
Acronym A randomized controlled trial using digital device providing visualized brushing instruction
Scientific Title A randomized controlled trial using digital device providing visualized brushing instruction
Scientific Title:Acronym A randomized controlled trial using digital device providing visualized brushing instruction
Region
Japan

Condition
Condition periodontal disease
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate whether brushing teeth using a device (GUM PLAY) that can perform brushing instruction linked with a mobile application contributes to acquire appropriate brushing habit and plaque removal better than using usual brushing.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The value of plaque control record (PCR) at week 4 of the test.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Before the test, the study participants receive teeth brushing for dental plaque removal by the dental hygienist, and teeth bushing instructions by viewing a video material. Furthermore, the participants brush their teeth with the guidance for four weeks using the toothbrush with the digital device (GUM PLAY) that has guide application function for brushing teeth.
Interventions/Control_2 Before the test, the study participants receive teeth brushing for dental plaque removal by the dental hygienist, and teeth bushing instructions by viewing a video material. Furthermore, the participants brush their teeth as usual for four weeks using the toothbrush with the digital device (GUM PLAY) that has only the log collecting function of brushing.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria aged >=18 years old
Key exclusion criteria Persons who meet even one of the following criteria cannot be participated in this study.

1.Having severe crowded teeth (One third or more of the teeth overlapped and it is difficult to remove the dental plaque using only toothbrush)
2.Using interdental cleaning implement every day
3.Having external injury in oral cavity or stomatitis that can affect brushing teeth
4.Having less than 20 remaining teeth
5.Using orthodontic apparatus
6.Visited a dental clinic within a month
7.Having a possibility to consult a dental clinic during the examination period
8.Having license of dental fields
9.Not having smartphones or tablet devices
10.Smoker
11.Taking antibiotics within a week
12.Having a possibility of pregnancy
13.Having allergy to staining fluid for dental plaque
14.Employees of Sunstar Co., Ltd
Target sample size 190

Research contact person
Name of lead principal investigator
1st name Taku
Middle name
Last name Iwami
Organization Kyoto University
Division name Health Service
Zip code 6068501
Address Yoshida-Honmachi, Sakyo-ku, Kyoto 606-8501, Japan
TEL 075-753-2426
Email iwami.taku.8w@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Haruka
Middle name
Last name Shida
Organization Kyoto University School of Public Health
Division name Department of Preventive Services
Zip code 6068501
Address Yoshida-Honmachi, Sakyo-ku, Kyoto 606-8501, Japan
TEL 075-753-2431
Homepage URL
Email hamigaki_rct2018@hc2.hoken.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Health Services
Institute
Department

Funding Source
Organization Sunstar Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Sunstar Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都大学(京都府)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 20 Day

Related information
URL releasing protocol https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0235194
Publication of results Published

Result
URL related to results and publications https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0235194
Number of participants that the trial has enrolled 131
Results
The trial was conducted at Kyoto University Health Service from October 29th, 2018 to November 30th, 2018. 
  Among 118 enrolled individuals, 112 participants were eligible for our analyses. The mean of PCR score at week 4 was 45.05% in the intervention group and 49.65% in the control group, and the change of PCR score from baseline was -20.46% in the intervention group and -15.77% in the control group (p = 0.088, 95% confidence interval -0.70-10.07).
Results date posted
2020 Year 07 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Most of the participants were college students and the mean age of participants was 26.0 years in the intervention group and 25.0 years in the control group. The proportion of male was 48.2% in the intervention group and 51.8% in the control group. 
  The proportion of participants with a baseline PCR score >=60% was 58.9% in both groups, and the mean of the number of treated teeth was 3.4 in intervention group and 3.0 in control group.
Participant flow
A total of 131 participants were initially registered to take part in this trial. After excluding 11 participants who did not get in touch and 2 participants who could not connect to the brushing-instruction digital device, the remaining 118 participants were randomly assigned to either the intervention or control group. Of the 118 participants, 6 dropped out during follow-up. A total 112 participants were finally eligible for our analyses and the number in each group was 56 participants.
Adverse events
During this trial, adverse events and serious harms were not observed.
Outcome measures
Regarding the primary outcome, the mean 6-point method PCR score at week 4 was 45.05% in the intervention group and 49.65% in the control group, and the change of mean PCR score from baseline to week 4 in each group was -20.46% in the intervention group and -15.77% in the control group, indicating no statistically significant difference (p = 0.088, 95% confidence interval (95%CI) -0.70-10.07). The change of mean PCR score from baseline using the 4-point method as the secondary outcome was significantly greater in the intervention group (-18.09%) compared to the control group (-13.11%; p = 0.047, 95%CI 0.07-9.90). The change of mean PCR score from baseline to week 2 was -13.53% in the intervention group and-10.26% in the control group. 
  Moreover, the mean PCR score at week 4 decreased from baseline to a larger extent in the intervention group compared to the control group across all three surfaces parts (medial and distal surfaces, buccal center surfaces and lingual center surfaces) and two teeth locations (anterior teeth and posterior teeth).
  Regarding the results of the questionnaire survey regarding the consciousness of brushing teeth and time spent brushing teeth, the distribution of each consciousness question (Q1: Are you conscious of the brushing procedure?, Q2: Are you conscious of brushing each tooth surface?, Q3: Are you conscious of moving the toothbrush in small steps?) and brushing time were similar between the intervention and control groups at baseline. However, the number of participants who were consciousness of the brushing procedure after four weeks was 49 (87.5%) in the intervention group and 16 (28.6%) in the control group (p<0.001). Furthermore, the distribution of each consciousness and brushing time were different in the two groups at week 4. 
Plan to share IPD No
IPD sharing Plan description Public sharing and secondary use of the data used in this study is prohibited by the Kyoto University Institutional Review Board. However, other researchers may submit data access requests to the Research Promotion Division, General Affairs and Planning Section, Kyoto University Graduate School of Medicine and Faculty of Medicine (060kensui@mail2.adm.kyoto-u.ac.jp).

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 09 Month 14 Day
Date of IRB
2018 Year 06 Month 27 Day
Anticipated trial start date
2018 Year 10 Month 03 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 15 Day
Last modified on
2020 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037672

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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