UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019463
Receipt number R000022499
Scientific Title Hybrid resin crown restorations for anterior tooth using dental CAD/CAM system
Date of disclosure of the study information 2015/11/01
Last modified on 2021/10/26 11:45:20

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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 or person

Institute

Clinic of Fixed Prosthodontics, Nagasaki Univesity Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022499


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name