UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053774 |
|---|---|
| Receipt number | R000060817 |
| Scientific Title | Clinical evaluation of composite resin restorations using the Clear Index Technique with digital technology. |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/09/13 20:36:06 |
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Basic information
Public title
Clinical evaluation of composite resin restorations using the Clear Index Technique with digital technology.
Acronym
Clinical evaluation of composite resin restorations using the Clear Index Technique with digital technology.
Scientific Title
Clinical evaluation of composite resin restorations using the Clear Index Technique with digital technology.
Scientific Title:Acronym
Clinical evaluation of composite resin restorations using the Clear Index Technique with digital technology.
Region
| Japan |
Condition
Condition
Dental caries, crown fracture, dwarf teeth, Missing tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine what advantages the Clear Index technique, which utilises digital technology, offers in terms of quality and efficiency compared to traditional composite resin restoration methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of dimensional accuracy in composite resin restorations using the clear index technique in the experimental group and the conventional method in the control group.
Key secondary outcomes
Evaluating treatment time: measurement of the time required to treat composite resin restorations.
Esthetic assessment: surface gloss, colouration, tone and transparency, aesthetic anatomical morphology, material fracture and retention, etc.
Assessment of functional properties: margin fit, wear, patient opinion, presence of hypersensitivity, etc.
Assessment of biological characteristics: secondary caries, condition of periodontal tissue, condition of mucosa, oral and systemic health.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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 | Maneuver |
Interventions/Control_1
Composite resin restorations using the 'Clear Index Technique'. The 'index technique' is a restorative technique in which a clear index (transparent mould) is used, the flowable composite resin is loaded into the required area between the dentition and the dentition, and light-cured using a blue light LED irradiator.
Interventions/Control_2
Perform conventional composite resin restorations. Apply composite resin restorations according to standard operative procedures.
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
| 6 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals requiring composite resin restoration for permanent teeth.
Key exclusion criteria
Individuals with extremely poor oral hygiene.
Persons suffering from severe periodontitis in the entire jaw.
Those who are pregnant or breastfeeding.
Individuals with serious systemic diseases (such as severe diabetes, cardiovascular diseases).
Persons with a history of allergies (especially to resin materials or silicon).
Individuals deemed unable to participate in the study due to mental illnesses or dementia.
Others whom the principal investigator deems inappropriate for participation in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Hosaka |
Organization
Tokushima University Graduate School
Division name
Institute of Biomedical Sciences
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7340
hosaka@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Takegawa |
Organization
Tokushima University Graduate School
Division name
Institute of Biomedical Sciences
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7340
Homepage URL
d-takegawa@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
ASO International Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramotocho, Tokushima
Tel
088-633-7958
brinshoshienk@tokushima-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060817
