Unique ID issued by UMIN | UMIN000034604 |
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Receipt number | 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 | 2020/12/11 19:43:39 |
Clinical Trial of Bite Guard for Oral Treatment
A questionnaire-based, noninterventional, noninvasive, and prospective study
Clinical Trial of Bite Guard for Oral Treatment
Clinical Trial of Bite Guard for Oral Treatment
A questionnaire-based, noninterventional, noninvasive, and prospective study
Clinical Trial of Bite Guard for Oral Treatment
Japan |
Oral Care / Difficulty in keeping mouth open by oneself
Dental medicine |
Others
NO
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.
Safety
Incidence of problems during treatment using the bite guard
Observational
Not applicable |
Not applicable |
Male and Female
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.
> 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.
30
1st name | Takashi |
Middle name | |
Last name | YURIKUSA |
Shizuoka Cancer Center
Division of Dentistry and Oral Surgery
411-8777
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan
055-989-5222
t.yurikusa@scchr.jp
1st name | Takashi |
Middle name | |
Last name | YURIKUSA |
Shizuoka Cancer Center
Division of Dentistry and Oral Surgery
411-8777
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan
055-989-5222
t.yurikusa@scchr.jp
Shizuoka Cancer Center
Nissho-Sangyo Co., Ltd.
Profit organization
Suntou Dental Association
Shizuoka Cancer Center IRB
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan
055-989-5222
tansaku_office@scchr.jp
NO
2018 | Year | 10 | Month | 23 | Day |
Unpublished
No longer recruiting
2018 | Year | 08 | Month | 28 | Day |
2018 | Year | 08 | Month | 28 | Day |
2018 | Year | 10 | Month | 19 | Day |
2021 | Year | 12 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
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
2018 | Year | 10 | Month | 23 | Day |
2020 | Year | 12 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038742
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