UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017951
Receipt number 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 19:47:20

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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 or person

Institute

Kyushu University Faculty of Dental Science
Implant and Rehabilitative Dentistry

Institute

Department

Personal name



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

Value
https://center6.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