UMIN-CTR Clinical Trial

Basic information
Public title	Secondary stress reduction effect in using a rubber dam
Acronym	Secondary stress reduction effect in using a rubber dam
Scientific Title	Secondary stress reduction effect in using a rubber dam
Scientific Title:Acronym	Secondary stress reduction effect in using a rubber dam
Region	Japan

Condition
Condition	dental caries
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In response to the CQ, "Does the use of the rubber dam moisture-proof method reduce patient stress?" The purpose is to confirm the distribution of the data for the RQ "" and to obtain summary statistics.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire results before and after treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	1st time rubber dam used, 2nd time rubber dam not used
Interventions/Control_2	1st time rubber dam used, 2nd time rubber dam not used
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	Patients who visit Nagasaki University and undergo filling a cavity or preparation for inlay cavity under the usual method. Patients over 18 years old
Key exclusion criteria	Patients who cannot answer the questionnaire by themselves Patients with contraindications to use Epilide as a local anesthetic (severe hypertension, hyperthyroidism) Patients with serious respiratory disease Patients who are judged to be inappropriate as research subjects by the operator or reseach director
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Nobuaki Middle name Last name Magata
Organization	Nagasaki University Hospital
Division name	Department of Dental anesthesiology
Zip code	8528501
Address	1-7-1 Sakamoto,NagaskiCity,Nagasaki,Japan
TEL	0958197748
Email	magata@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Nobuaki Middle name Last name Magata
Organization	NAGASAKI University Hospital
Division name	Department of Dental anesthesiology
Zip code	8528501
Address	1-7-1 Sakamoto,NagaskiCity,Nagasaki,Japan
TEL	0958197748
Homepage URL
Email	magata@nagasaki-u.ac.jp

Sponsor
Institute	NAGASAKI University Hospital
Institute
Department

Funding Source
Organization	self-procurement
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nagasaki University Hospital Clinical Reserch Ethics Commitee
Address	1-7-1Sakamoto,NagasakiCity,NAGASAKI,Japan
Tel	0958197229
Email	magata@nagasaki-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

Other administrative information
Date of disclosure of the study information	2022 Year 10 Month 01 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	Preinitiation
Date of protocol fixation	2022 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 22 Day
Last follow-up date	2023 Year 09 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	2022 Year 09 Month 27 Day
Last modified on	2022 Year 09 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055501