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
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
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
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
