UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047395 |
|---|---|
| Receipt number | R000054044 |
| Scientific Title | Longevity of dental restorations: A multicenter study |
| Date of disclosure of the study information | 2022/04/06 |
| Last modified on | 2023/10/12 10:30:20 |
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Basic information
Public title
Longevity of dental restorations: A multicenter study
Acronym
Longevity of dental restorations
Scientific Title
Longevity of dental restorations: A multicenter study
Scientific Title:Acronym
Longevity of dental restorations: A multicenter study
Region
| Japan |
Condition
Condition
dental caries, missing tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survival times of various dental restorations (resin composites, metal inlays, metal crowns, facing crowns, and bridges) will be investigated at several collaborating institutions (general dental practices), and these data will be integrated to estimate survival rates at 10, 15, and 20 years to determine their longevity (median survival time).
Basic objectives2
Others
Basic objectives -Others
Longer-lasting restorative treatment prolongs the life of teeth and contributes to healthier life expectancy through the maintenance of oral function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event occurrence.
An event in this study refers to the need for re-treatment (including replacement, repair and extraction) due to caries, fracture, or dislodgement.
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients must have visited each dental clinic during the study recruitment period and at least 10 years must have passed since the date of their first visit at that time.
2.The patient must have received restorative or prosthetic crown treatment at the respective dentist's practice.
3.The participant's informed consent must have been obtained verbally.
Key exclusion criteria
1.Participants must not have been a patient for more than 10 years after the initial visit.
2.minor
3.Patients with no history of restorative treatment at the collaborating institution
4.Record only the first treatment case by treatment method and exclude the second and subsequent cases.
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Yohsuke |
| Middle name | |
| Last name | Taira |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Division of Cariology and Restorative Dentistry
Zip code
852-8588
Address
1-7-1, Sakamoto, Nagasaki, 852-8588, japan
TEL
095-819-7677
yohsuke@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shisei |
| Middle name | |
| Last name | Kubo |
Organization
Nagasaki University School of Dentistry
Division name
Department of Prosthetic Dentistry
Zip code
852-8588
Address
1-7-1, Sakamoto, Nagsaki, 852-8588, Japan
TEL
095-819-7677
Homepage URL
kuboshisei@gmail.com
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Biomedical Sciences, Division of Cariology and Restorative Dentistry
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Maruyama Dental Clinic, Hayama Dental Clinic, Ooi Dental Office, Nanba Dental Clinic, Horisaka Dental Clinic, Yamamoto Dental Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
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、丸山歯科医院、羽山歯科医院、おおい歯科、難波歯科医院、堀坂歯科医院、山本歯科クリニック
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
At present, URL is not avialable.
Publication of results
Partially published
Result
URL related to results and publications
At present, URL is not avialable.
Number of participants that the trial has enrolled
900
Results
Information about survival time of 819 restorations was obtained from 572 participants in 6 general dental practices. The median survival time was 25.5 years for 544 composite resin restorations and 17.6 years for 275 metal inlay restorations. Survival time of 824 cast crowns was obtained from 682 participants. The median survival times were 25.6 years for 542 metal crowns and 24.3 years for 282 facing crowns. Ten-year and 20-year survival rates of endodontic treatment were 92.0% and 84.1%.
Results date posted
| 2023 | Year | 04 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All participants (20 years or older) who had first visited respective dental clinics more than 10 years ago had a history of resin composite restorations, metal inlays, full cast crowns, facing cast crowns and/or bridges placement by the six dentists. The participants visited each dental clinic during the study period (March 22-April 30, 2022), where they received an explanation of the purpose of the study and gave their consent. To reduce selection bias, information about only the initially placed respective types of restorations was obtained from the medical charts and recorded in the case report form.
Participant flow
There were no dropouts among participants since this clinical study is an observational study.
Adverse events
No adverse events were observed in this clinical study because it was an observational study.
Outcome measures
Clinical performance
Survival time of restorations
Reasons for retreatment, such as caries adjacent to the restorations, loss of restorations, tooth fracture, material fracture, root fracture, discoloration, periapical lesion, pulpitis, periodontitis, etc.
Factors that may affect survival time (operator, participant age at placement, remaining teeth at placement, category of restoration, time, retreatment risk, maintenance, teeth loss during follow-up period, tooth type, location)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 18 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 10 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 31 | Day |
Other
Other related information
Survival time is defined as the age when the restoration was replaced, repaired or tooth extracted.
If the restorations still survive at the end of the study, they are treated as censored cases.
Management information
Registered date
| 2022 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054044
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/04/20 | 研究計画書第3版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/04/20 | 症例報告書 2版.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/04/20 | 解析原本 20220701.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/54044
