UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056674 |
|---|---|
| Receipt number | R000064749 |
| Scientific Title | Investigation on application effects of CAD/CAM crowns compared to preformed metal crown for deciduous teeth |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/07/11 17:03:15 |
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Basic information
Public title
Investigation on application effects of CAD/CAM crowns compared to preformed metal crown for deciduous teeth
Acronym
Investigation on application effects of CAD/CAM crowns compared to preformed metal crown for deciduous teeth
Scientific Title
Investigation on application effects of CAD/CAM crowns compared to preformed metal crown for deciduous teeth
Scientific Title:Acronym
Investigation on application effects of CAD/CAM crowns compared to preformed metal crown for deciduous teeth
Region
| Japan |
Condition
Condition
caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform CAD/CAM crown restorations on deciduous teeth that require full restorations and analyze the treatment results. The results obtained will be used to evaluate the effectiveness of CAD/CAM crown restorations for deciduous teeth.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence and extent of findings (fracture, dehiscence, secondary caries) on the treated tooth at 3 months, 6 months, 1 year, and every year thereafter until the eruption of the succeeding permanent tooth, and the presence and extent of radiographic findings (margin fit, secondary caries) should be evaluated to determine the success or failure of the procedure.
If an extracted treated tooth is obtained, it should be observed under a scanning electron microscope and its fit to the abutment tooth should be documented.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
CAD/CAM crown are performed on primary teeth that require full restoration. After crown restoration, no intervention is necessary without prognostic or other reasons, but an intraoral examination and radiographic examination should be performed to determine prognostic or other reasons.
Interventions/Control_2
Preformed metal crown are performed on primary teeth that require full restoration. After crown restoration, no intervention is necessary without prognostic or other reasons, but an intraoral examination and radiographic examination should be performed to determine prognostic or other reasons.
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
| 3 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children aged 3 to 9 years who visited Tokyo Dental College Suidobashi Hospital and Chiba Dental Medical Center between December 25, 2024 and March 31, 2029 who have baby teeth requiring full restorations will be eligible.
Key exclusion criteria
Research subjects who cannot get a ferrule of 1.5 mm or more on the abutment tooth
Research subjects with significant occlusal wear that could be expected to cause abnormal occlusal forces on the crowns
Research subjects who have failed to make at least two follow-up visits or examinations within a minimum of two years after treatment
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tanaka |
| Middle name | |
| Last name | Aoi |
Organization
Tokyo Dental College
Division name
Department of Pediatric Dentistry
Zip code
101-0061
Address
2-9-18, Kanda Misaki-cho, Chiyoda-ku, Tokyo, 101-0061, Japan
TEL
03-3262-3421
tanakaaoi@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Tanaka |
| Middle name | |
| Last name | Aoi |
Organization
Tokyo Dental College
Division name
Department of Pediatric Dentistry
Zip code
101-0061
Address
2-9-18, Kanda Misaki-cho, Chiyoda-ku, Tokyo, 101-0061, Japan
TEL
03-3262-3421
Homepage URL
tanakaaoi@tdc.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Dental College
Address
2-9-18, Kanda Misaki-cho, Chiyoda-ku, Tokyo, 101-0061, Japan
Tel
03-3262-3421
tanakaaoi@tdc.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064749
