UMIN-CTR Clinical Trial

Basic information
Public title	Study using cements for cavities on root
Acronym	Study using cements for cavities on root
Scientific Title	Prospective observational study using restorative materials for root caries
Scientific Title:Acronym	Prospective observational study using restorative materials for root caries
Region	Japan

Condition
Condition	Root caries
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the incidence of secondary caries after filling CAREDYNE RESTORE which is glass ionomer cement contained zinc
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Biological properties: 9.Recurrence of caries, erosion, abfraction the fillings are assessed before treatment, at 3 months, 6 months and 1 year after the treatment
Key secondary outcomes	-Aesthetic properties: 1.Surface luster 2.Staining (a. surface, b. margin) 3.Esthetic anatomical form -Functional properties: 4.Fracture and retention 5.Marginal adaptation 6.Wear 7.Radiographic examination -Biological properties: 8.Postoparative (hyper-) sensitivity and tooth vitality

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	65 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who has both side of maxillary anterior teeth which are vital and have root caries on buccal side which should be restored by CAREDYNE RESTORE (GC).
Key exclusion criteria	Patients who have temporomandibular joint disorder, xerostomia, dementia and mental aliments
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Masanao Middle name Last name Inokoshi
Organization	Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name	Department of Gerodontology and Oral Rehabilitation
Zip code	1138510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	0358035584
Email	m.inokoshi.gerd@tmd.ac.jp

Public contact
Name of contact person	1st name Masanao Middle name Yamamoto Last name Inokoshi
Organization	Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name	Department of Gerodontology and Oral Rehabilitation
Zip code	1138510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	0358035585
Homepage URL
Email	m.inokoshi.gerd@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Self-funding
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	Ethics Committee of the Faculty of Dentistry, TMDU
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel	03-5803-5404
Email	d-hyoka.adm@tmd.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	2020 Year 09 Month 30 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	2020 Year 07 Month 01 Day
Date of IRB	2022 Year 05 Month 06 Day
Anticipated trial start date	2022 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To reveal the incidence of secondary caries after filling glass ionomer cement contained zinc. The fillings are assessed before treatment, at 3 months, 6 months and 1 year after the treatment

Management information
Registered date	2020 Year 07 Month 07 Day
Last modified on	2022 Year 07 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046854