UMIN-CTR Clinical Trial

Basic information
Public title	A study on the longevity of resin composite and cast restorations
Acronym	A study on the longevity of resin composite and cast restorations
Scientific Title	A study on the longevity of resin composite and cast restorations
Scientific Title:Acronym	A study on the longevity of resin composite and cast restorations
Region	Japan

Condition
Condition	Dental caries and fracture of tooth and/ or restorative materials
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to provide more reliable evidence, long-term clinical performances of resin composite and cast restorations were investigated by using patients records. To determine the cause of the re-treatment may be able to lead not only to improvement and development of restorative materials and techniques but also to prevent a recurrence.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Restorations were examined and rated clinically acceptable, clinically unacceptable or already replaced according to the FDI criteria. Survival time was defined as the age when the restoration was replaced, repaired, tooth extracted or diagnosed the need for such treatments.
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	-Patients research leader was responsible since 1995. - Patients from the document consent has been example cases (relocation, health, can not visit for reasons such as death, for those who agree in writing can not be obtained, to carry out information disclosure)
Key exclusion criteria	none
Target sample size	1300

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shisei Kubo
Organization	Nagasaki University Hospital
Division name	Medical Education Development Center
Zip code
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7533
Email	kubo@nagasaki-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Shisei Kubo
Organization	Nagasaki University Hospital
Division name	Medical Education Development Center
Zip code
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7533
Homepage URL
Email	kubo@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	none
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
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 10 Month 10 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	Completed
Date of protocol fixation	2015 Year 09 Month 10 Day
Date of IRB	2015 Year 09 Month 10 Day
Anticipated trial start date	2015 Year 09 Month 16 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1.Kubo S: Longevity of resin composite restorations. JDSR, 47: 43-55, 2011. 2.Survival rate of composite resin and casting repair; Japan Conservative Dentistry Journal,44,802-809,2001. 3.Kubo S, Kawasaki A, Hayashi Y: Factors associated with the longevity of resin composite restorations, Dent Mater J, 30: 374-383, 2011. 4.Nippon Dental save Gakkai. Second edition caries treatment guidelines,Kyoto,2015

Management information
Registered date	2015 Year 09 Month 29 Day
Last modified on	2019 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022137