UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028745
Receipt number 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 2021/08/26 16:58:46

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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 Shisei
Middle name
Last name Kubo

Organization

Nagasaki University Hospital

Division name

Medical Education Development Center

Zip code

852-8588

Address

1-7-1 Sakamoto,Nagasaki

TEL

095-819-7757

Email

kubo@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Shisei
Middle name
Last name Kubo

Organization

Nagasaki University Hospital

Division name

Medical Education Development Center

Zip code

852-8588

Address

1-7-1 Sakamoto,Nagasaki

TEL

095-819-7757

Homepage URL


Email

kubo@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



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

Nagasaki University Hospital

Address

1-7, Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan

Tel

095-819-7905

Email

gaibushikin@ml.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

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

Completed

Date of protocol fixation

1998 Year 03 Month 01 Day

Date of IRB

2017 Year 04 Month 18 Day

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

2021 Year 08 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032894


Research Plan
Registered date File name
2020/08/21 研究計画書 v3.3.docx

Research case data specifications
Registered date File name
2022/10/09 Clin Oral Invest 202207.pdf

Research case data
Registered date File name