UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028745
Receipt No. R000032894
Scientific Title Observational study on clinical performance of resin composite restorations in non-carious cervical lesions
Date of disclosure of the study information 2017/09/01
Last modified on 2018/02/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Observational study on clinical performance of resin composite restorations in non-carious cervical lesions
Acronym Clinical performance of resin composite restorations in non-carious cervical lesions
Scientific Title Observational study on clinical performance of resin composite restorations in non-carious cervical lesions
Scientific Title:Acronym Clinical performance of resin composite restorations in non-carious cervical lesions
Region
Japan

Condition
Condition Non-carious cervical lesions
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The prevalence of non-carious cervical lesions (NCCLs) would likely increase as a nation's population ages and as the survival times of teeth increase. The aim of this study is to investigate long-term clinical performance of resin composite restorations in NCCLs and contribute to evidence-based medicine.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Retention failure
Marginal staining
Wear
Key secondary outcomes Secondary caries
Marginal adaptation
Discoloration
Sensitivity
Recurrent NCCL
Gum recession

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
29 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients, who were under the charge of the principal investigator (SK) and had regularly visited the Department of Conservative Dentistry, Nagasaki University Hospital, with 2 and more NCCLs
2. Patients after receiving a sufficient explanation upon participation in this study, on the thorough understanding, that document consent is obtained due to free will of the patient's own.
3. Resin composite restorations placed in NCCLs between February 1 and June 30, 1998, and between May 1 and November 30, 2005
Key exclusion criteria No consideration was given to medical history, periodontal condition, caries risk, occlusion and tooth wear.
Target sample size 35

Research contact person
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 095-819-7757
Email kubo@nagasaki-u.ac.jp

Public contact
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 095-819-7757
Homepage URL
Email kubo@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
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 長崎大学病院(長崎県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1. Kubo S, Yokota H, Kawasaki K. Hayashi Y. Five-year clinical evaluation of two adhesive systems in non-carious cervical lesions, J Dent 34 (2), 97-105, 2006.
2. Kubo S, Yokota H, Yokota H, Hayashi Y: Two-year Clinical Evaluation of One-step Self-etch Systems in Non-carious Cervical Lesions, J Dent 37 (2), 149-155, 2009.
3. Kubo S, Yokota H, Yokota H, Hayashi Y: Three-year Clinical Evaluation of a Flowable and a Hybrid Resin Composite in Non-carious Cervical Lesions, J Dent 38 (2), 191-200, 2010. 
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 No longer recruiting
Date of protocol fixation
1998 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
1998 Year 03 Month 01 Day
Last follow-up date
2020 Year 12 Month 28 Day
Date of closure to data entry
2020 Year 12 Month 28 Day
Date trial data considered complete
2020 Year 12 Month 28 Day
Date analysis concluded
2021 Year 02 Month 28 Day

Other
Other related information Short-term and medium-term clinical results have already published above. More longer-term clinical performances of resin composite restorations placed in NCCLs are planed to be investigated in the present observational study.

Management information
Registered date
2017 Year 08 Month 19 Day
Last modified on
2018 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032894

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.