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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017951
Receipt No. R000020683
Scientific Title The safety of Fiber-reinforced hydrid composite fixed partial dentures: a prospective cohort study.
Date of disclosure of the study information 2015/06/17
Last modified on 2015/06/17

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Basic information
Public title The safety of Fiber-reinforced hydrid composite fixed partial dentures: a prospective cohort study.
Acronym The safety of Fiber-reinforced hydrid composite fixed partial dentures: a prospective cohort study.
Scientific Title The safety of Fiber-reinforced hydrid composite fixed partial dentures: a prospective cohort study.
Scientific Title:Acronym The safety of Fiber-reinforced hydrid composite fixed partial dentures: a prospective cohort study.
Region
Japan

Condition
Condition single tooth loss
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assess the safety of Fiber-reinforced hydrid composite fixed partial dentures in patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 12-month survival rates after treatment with the fixed partial dentures
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
Other
Interventions/Control_1 Prosthetic treatment with fiber-reinforced hydrid composite fixed partial denture in single tooth loss
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. Subjects (male and female) aged 20 years or older who show their agreement to take part in the study
2. Subjects who lost second primolar or first molar in maxilla
3. Subjects who lost second primolar or first molar in mandibula
4. Subjects with restorable medial and distal adjacent teeth to the missing tooth.
5. Subjects with natural or restored opposing tooth
6. Subjects with control of periodontal disease, and with good oral hygiene
7. Subjects with the distance between abutment teeth 15mm or less
8. Subjects with the ratio between the height of abutment teeth and the distance between abutment teeth is 0.5 or more
9. Subjects with sufficient occlusal cleaeance;1.5-2.0mm
10. Subjects with the abutment tooth height 0.8mm-1mm or more in molar, and 0.5-0.8mm or more in premolar
Key exclusion criteria 1. Subjects with a resin allergy (skin rash, dermatitis, etc)
2. Subjects with a systemic disease that may affect the treatment (heart desease, cerebrovascular disease,etc)
3. Subjects who plan to participate in other clinical trial, or investigation 30 days prior to or during this study
4. Subjects who are pregnant or nursing or subjects who plan to be pregnant during this study
5. Subjects who cannot understand this study or subjects that the investigator deems ineligible to participate in this study
6. Subjects with malocclusion and/or severe habits of bruxism
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Koyano
Organization Kyushu University Faculty of Dental Science
Division name Implant and Rehabilitative Dentistry
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan
TEL 092-642-6376
Email koyano@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Kihara
Organization Kyushu University Faculty of Dental Science
Division name Implant and Rehabilitative Dentistry
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan
TEL 092-642-6441
Homepage URL
Email kihara@dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Faculty of Dental Science
Implant and Rehabilitative Dentistry
Institute
Department

Funding Source
Organization GC Corporation
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
Address
Tel
Email

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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 17 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
2015 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 06 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
2015 Year 06 Month 17 Day
Last modified on
2015 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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