UMIN-CTR Clinical Trial

Basic information
Public title	Hybrid resin crown restorations for anterior tooth using dental CAD/CAM system
Acronym	Hybrid resin crown restorations for anterior tooth
Scientific Title	Hybrid resin crown restorations for anterior tooth using dental CAD/CAM system
Scientific Title:Acronym	Hybrid resin crown restorations for anterior tooth
Region	Japan

Condition
Condition	tooth decay, treated tooth
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to evaluate clinical performance of habrid resin crown restorations which improved homogeneity and a surface property as material at anterior tooth
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adaptation of CAD/CAM crowns A: the border accept it if not recognize CAD/CAM crown and the border with the tooth plane with a explorer B: it is possible and does the gap with impossibility C:if both the border and the gap admit D: if there are fracture and/or the detachment of crown
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	CAD/CAM hybrid resin rerstorations for anterior tooth
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The patient that a document agreement by the free will of a patient was provided after enough understanding after having received enough explanation on participating to this study
Key exclusion criteria	The applicable patient intends for even one following conditions and excludes it. 1. Inappropriate abutment tooth (when there is the apical lesion) of the root canal treatment 2. Of the alveolar bone level when is low (when an alveolar bone level decreases more than 1/2) 3. When it is inappropriateness of the abutment construction 4. Buraxismcase with remarkable attrition 5. The case that the clearance of the occlusal surface cannot secure 6. When it becomes the abutment tooth of the removable partial denture 7. Of the opposing tooth when there is not it 8. Opposing tooth in the case of artificial teeth of removable partial denture 9. When, for a meta chestnut rate system polymer, there is an anamnesis of hypersensitivity such as a rash, dermatitis
Target sample size	47

Research contact person
Name of lead principal investigator	1st name Keiichi Middle name Last name Yoshida
Organization	Nagasaki Univesity Hospital
Division name	Clinic of Fixed Prosthodontics
Zip code	8528588
Address	1-7-1, Sakamoto, Nagasaki
TEL	095-819-7688
Email	keiichi@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Keiichi Middle name Last name Yoshida
Organization	Nagasaki Univesity Hospital
Division name	Clinic of Fixed Prosthodontics
Zip code	8528588
Address	1-7-1, Sakamoto, Nagasaki
TEL	095-819-7688
Homepage URL
Email	keiichi@nagasaki-u.ac.jp

Sponsor
Institute	Clinic of Fixed Prosthodontics, Nagasaki Univesity Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nagasaki University Hospital
Address	1-7-1, sakamoto, Nagasaki
Tel	095-819-7744
Email	keichi@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	2015 Year 11 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	Terminated
Date of protocol fixation	2015 Year 10 Month 15 Day
Date of IRB	2015 Year 10 Month 15 Day
Anticipated trial start date	2015 Year 11 Month 16 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 22 Day
Last modified on	2021 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022499