UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034604
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

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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 Takashi
Middle name
Last name YURIKUSA

Organization

Shizuoka Cancer Center

Division name

Division of Dentistry and Oral Surgery

Zip code

411-8777

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 Takashi
Middle name
Last name YURIKUSA

Organization

Shizuoka Cancer Center

Division name

Division of Dentistry and Oral Surgery

Zip code

411-8777

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan

TEL

055-989-5222

Homepage URL


Email

t.yurikusa@scchr.jp


Sponsor or person

Institute

Shizuoka Cancer Center

Institute

Department

Personal name



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

Shizuoka Cancer Center IRB

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan

Tel

055-989-5222

Email

tansaku_office@scchr.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



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

No longer recruiting

Date of protocol fixation

2018 Year 08 Month 28 Day

Date of IRB

2018 Year 08 Month 28 Day

Anticipated trial start date

2018 Year 10 Month 19 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 12 Month 31 Day


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

2020 Year 12 Month 11 Day



Link to view the page

Value
https://center6.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