UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016569
Receipt number R000019220
Scientific Title Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth.
Date of disclosure of the study information 2015/02/18
Last modified on 2015/02/17 21:18:39

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Basic information

Public title

Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth.

Acronym

Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth.

Scientific Title

Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth.

Scientific Title:Acronym

Clinical assessment of CAD/CAM produced crown with hybrid resin (Sera Smart) for molar teeth.

Region

Japan


Condition

Condition

Caries of a molar tooth

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to estimate the clinical validity of CAD/CAM prosuced hybrid resin crowm for molar teeth by follow up.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

crack/fracture of crown, deslocated, condition of occlusal contact, condition of occlusal surface of crown/antagonistic teeth, crown color, plaque build-up, condition of interproximal contact, necessity of retreatment, pain, second caries

Key secondary outcomes

condition of metal allergy


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

application of CAD/CAM hybrid resin crown for molar teeth

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

treatment by crown for molar teeth, sufficient occlusal cleaeance, antagonistic teeth are existed

Key exclusion criteria

abutement tooth is infected by periodontal disease/apical periodontitis, clasped tooth, bruxism

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuo Ichikawa

Organization

The university of Tokushima

Division name

Department of Oral and Maxillofacial Prothodontics

Zip code


Address

3-18-15, Kuramoto-cho, Tokushima-shi, Tokushima 770-8504, JAPAN

TEL

0886-33-7347

Email

ichi@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Ishida

Organization

The university of Tokushima

Division name

Department of Oral and Maxillofacial Prothodontics

Zip code


Address

3-18-15, Kuramoto-cho, Tokushima-shi, Tokushima 770-8504, JAPAN

TEL

0886-33-7347

Homepage URL


Email

junchan@tokushima-u.ac.jp


Sponsor or person

Institute

Department of Oral and Maxillofacial Prothodontics

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


Address


Tel


Email



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 02 Month 18 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

2015 Year 01 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 17 Day

Last modified on

2015 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019220


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name