UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study to introduce "a metal-free glass-fiber reinforced 3-unit composite resin bridge" as an advanced medical treatment
Title of the study (Brief title)	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	Hiroshi Egusa
Organization	Tohoku university graduate school of dentistry
Division name	Division of Molecular and Regenerative Prosthodontics
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL	022-717-8363
Email	egu@dent.tohoku.ac.jp

Public contact
Name of contact person	Akio Harada
Organization	Tohoku university graduate school of dentistry
Division name	Division of Molecular and Regenerative Prosthodontics
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL	022-717-8363
Homepage URL
Email	akio.harada.a6@tohoku.ac.jp

Sponsor
Institute	Division of Molecular and Regenerative Prosthodontics, Tohoku University Graduate School of Dentistry
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029382