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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034604
Receipt No. R000038742
Scientific Title Clinical Trial of Bite Guard for Oral Treatment A questionnaire-based, noninterventional, noninvasive, and prospective study
Date of disclosure of the study information 2018/10/23
Last modified on 2019/03/05

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Basic information
Public title Clinical Trial of Bite Guard for Oral Treatment
A questionnaire-based, noninterventional, noninvasive, and prospective study
Acronym Clinical Trial of Bite Guard for Oral Treatment
Scientific Title Clinical Trial of Bite Guard for Oral Treatment
A questionnaire-based, noninterventional, noninvasive, and prospective study
Scientific Title:Acronym Clinical Trial of Bite Guard for Oral Treatment
Region
Japan

Condition
Condition Oral Care / Difficulty in keeping mouth open by oneself
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Bite guards, used by dentists and dental hygienists for oral care, examinations, and treatments, help to facilitate holding the mouth open during dental treatment. Recently, during oral care, a finger guard broke and caused a fatal accident. To resolve various problems, a more reliable and safer bite guard for oral treatment was developed ("the bite guard") through collaboration with Suntou Dental Association (SDA), Nissho-Sangyo Co., Ltd., and Sunstar Inc. as part of Shizuoka Pharma Valley Initiatives. The objective of this study is to evaluate the clinical usability and safety of this new design in cooperation with the Division of Dentistry and Oral Surgery of Shizuoka Cancer Center.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of problems during treatment using the bite guard
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The study involves 2 groups: patients with difficulty in keeping their mouths open during oral care, examinations, and treatments; and to assist the dentists and the dental hygienists who will use the bite guards when treating these patients.

1. Dentists and dental hygienists
> Dentists and dental hygienists who will use the bite guard when providing oral care, examinations, and treatments for the above-mentioned patients.
> Dentists and dental hygienists with experience in oral care, examinations and treatments.
> Dentists and dental hygienists who consent to cooperate with this study.

2. Patients
> Patients who are scheduled for oral care, examinations, and treatment at Shizuoka Cancer Center Hospital, at dental offices of SDA members, or at the patients' home.
> Patients with difficulty in keeping their mouths open.
> Patients who or whose representatives cooperate with this study after being provided with written explanation.
Key exclusion criteria > Patients who have already received care, examinations, and treatments using the bite guard.
> Patients requiring invasive and irreversible procedures (surgical procedures such as tooth extraction, dental pulp extraction, caries removal, etc.).
> Patients regarded as inappropriate for this study by the researcher in charge.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi YURIKUSA
Organization Shizuoka Cancer Center
Division name Division of Dentistry and Oral Surgery
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan
TEL 055-989-5222
Email t.yurikusa@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi YURIKUSA
Organization Shizuoka Cancer Center
Division name Division of Dentistry and Oral Surgery
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan
TEL 055-989-5222
Homepage URL
Email t.yurikusa@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Nissho-Sangyo Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Suntou Dental Association
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Dentists and dental hygienists will respond to a questionnaire to evaluate the finger guard.
1. Questions for dentists and dental hygienists
Patients' backgrounds
1) Age
2) Sex
3) Presence/absence of systemic disorder and name of the diagnosis
4) Location of care/examination/treatment
5) Date of care/examination/treatment

Evaluation items
1) The patient's position when treated using the bite guard
2) Duration of the use
3) Circumstance and frequency of the use
4) Presence/absence of problems related to the bite guard
5) Convenience of the bite guard
6) Stability of the bite guard
7) Usability of the bite guard
8) Impression after use
9) Points to be improved

2. Questions regarding patients
1) Pain during treatment using the bite guard
2) Discomfort in the oral cavity during treatment using the bite guard


Management information
Registered date
2018 Year 10 Month 23 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038742

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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