UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063418 |
|---|---|
| Receipt number | R000072581 |
| Scientific Title | Three-unit fixed dental prosthesis treatment using glass fiber-reinforced resin and hybrid composite resin fabricated with a dental CAD/CAM system |
| Date of disclosure of the study information | 2026/10/26 |
| Last modified on | 2026/10/26 14:02:16 |
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Basic information
Public title
Three-unit fixed dental prosthesis treatment using glass fiber-reinforced resin and hybrid composite resin fabricated with a dental CAD/CAM system
Acronym
Clinical evaluation of three-unit fixed dental prostheses using glass fiber-reinforced resin
Scientific Title
Three-unit fixed dental prosthesis treatment using glass fiber-reinforced resin and hybrid composite resin fabricated with a dental CAD/CAM system
Scientific Title:Acronym
TRINIA Bridge Study
Region
| Japan |
Condition
Condition
Single-tooth bounded edentulous spaces in the anterior or posterior region.
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the clinical performance of three-unit fixed dental prostheses fabricated using CAD/CAM-milled glass fiber-reinforced resin (TRINIA) frameworks veneered with a hybrid composite resin (Ceramage Duo).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The survival rate of three-unit fixed dental prostheses fabricated using TRINIA frameworks over a 2-year follow-up period. Prosthesis survival will be assessed using survival analysis, with complications such as fracture and debonding defined as endpoints. Assessments will be performed at 6 months, 1 year, and 2 years after prosthesis placement.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Three-unit fixed dental prostheses are fabricated using CAD/CAM-milled glass fiber-reinforced resin (TRINIA) frameworks veneered with a hybrid composite resin (Ceramage Duo). The intaglio surfaces of the prostheses are treated by alumina airborne-particle abrasion and an adhesive pretreatment. The prostheses are then bonded to the prepared abutment teeth using a resin luting cement (ResiCem EX). Clinical follow-up examinations are performed at 6 months, 1 year, and 2 years after placement.
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
Adult patients aged 20 years or older.
Patients with a single-tooth bounded edentulous space in the anterior or posterior region who are eligible for treatment with a three-unit fixed dental prosthesis.
Patients who have provided written informed consent after receiving an explanation of the study.
Key exclusion criteria
Patients with severe systemic diseases or conditions expected to adversely affect the oral cavity.
Patients younger than 20 years or those unable to provide informed consent.
Patients with malocclusion or bruxism.
Patients whose abutment teeth are intended to serve as abutments for removable partial dentures.
Patients in whom adequate tooth preparation cannot be achieved.
Patients with insufficient available occlusal clearance.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Ogawa |
Organization
Tsurumi University
Division name
Department of Fixed Prosthodontics, School of Dental Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-580-8416
ogawa-t@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Ikawa |
Organization
Tsurumi University
Division name
Department of Fixed Prosthodontics, School of Dental Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-580-8416
Homepage URL
ikawa-tomoko@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsurumi University
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa
Tel
045-580-8318
kyoken@tsurumi-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
| 2026 | Year | 10 | Month | 26 | 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
| 2023 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 26 | Day |
Last modified on
| 2026 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072581
