UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025525 |
|---|---|
| Receipt number | R000029382 |
| Scientific Title | A clinical study to introduce "a metal-free glass-fiber reinforced 3-unit composite resin bridge" as an advanced medical treatment |
| Date of disclosure of the study information | 2017/01/10 |
| Last modified on | 2019/01/08 00:05:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A clinical study to introduce "a metal-free glass-fiber reinforced 3-unit composite resin bridge" as an advanced medical treatment
Acronym
A clinical study of glass-fiber reinforced 3-unit composite resin bridges
Scientific Title
A clinical study to introduce "a metal-free glass-fiber reinforced 3-unit composite resin bridge" as an advanced medical treatment
Scientific Title:Acronym
A clinical study of glass-fiber reinforced 3-unit composite resin bridges
Region
| Japan |
Condition
Condition
Missing second premolar or first molar with each side adjacent tooth.
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to treat patients with the fiber-reinforced composite resin bridges to obtain the eligibility for the advanced medical treatment and to investigate their complication rates and patients' satisfactions after the prosthetic treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate after 1, 3, 6, 12 months.
Periodontal condition (0: no particular, 1: moderate inflammation, 2: severe inflammation)
Bridge condition (0: no particular, 1: crack or minor fracture, 2: major fracture)
Bridge discoloration (0; no particular, 1; moderate discoloration, 2; severe discoloration)
Occlusal contact (0; no particular, 1; moderate occlusal surface abrasion, 2; severe occlusal abrasion)
Opposite tooth condition (0; no particular, 1; moderate occlusal surface abrasion, 2; tooth fracture)
Adjacent tooth condition (0; no particular, 1; caries or periodontitis around contact area)
Assessment after insertion (0; no particular, 1; acceptable (repairable), 2; unacceptable (unrepairable))
Patient's satisfaction:
Against chief complaint (0; good, 1; acceptable, 2; bad)
Aesthetic (0; good, 1; acceptable, 2; bad)
Pronunciation (0; good, 1; acceptable, 2; bad)
Mastication (0; good, 1; acceptable, 2; bad)
Key secondary outcomes
Measure bridge thickness
Evaluate occlusal surface wear (scanning electron microscopy)
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 |
Interventions/Control_1
Fiber reinforced composite resin bridge :Experia system (GC)
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
Patients missing second premolar or first molar with each side adjacent tooth existing.
Key exclusion criteria
Bruxism
Less tooth height
Less 2 mm clearance between opposite tooth
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Egusa |
Organization
Tohoku university graduate school of dentistry
Division name
Division of Molecular and Regenerative Prosthodontics
Zip code
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
022-717-8363
egu@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Harada |
Organization
Tohoku university graduate school of dentistry
Division name
Division of Molecular and Regenerative Prosthodontics
Zip code
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
022-717-8363
Homepage URL
akio.harada.a6@tohoku.ac.jp
Sponsor or person
Institute
Division of Molecular and Regenerative Prosthodontics, Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
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
Address
Tel
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 04 | Day |
Last modified on
| 2019 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029382
