UMIN-CTR Clinical Trial

Basic information
Public title	Calcium silicate-based materials used for non-surgical root canal treatment in mature permanent teeth: a systematic review
Acronym	Calcium silicate-based endodontic materials: a systematic review
Scientific Title	Calcium silicate-based materials used for non-surgical root canal treatment in mature permanent teeth: a systematic review
Scientific Title:Acronym	Calcium silicate-based endodontic materials: a systematic review
Region	Japan

Condition
Condition	asymptomatic irreversible pulpitis, asymptomatic necrosis and apical periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate randomized clinical trial of calcium silicate-based materials used for non-surgical root canal treatment in mature permanent teeth
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative pain
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Language: English 2. Effectiveness of calcium silicate-based materials for root canal treatment
Key exclusion criteria	1. Not RCTs 2. Vital pulp therapy, Pulpotomy, Endodontic microsurgery 3. Primary teeth, Immature permanent teeth 4. In vitro studies, Animal studies
Target sample size

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Matsuura
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Periodontology and Endodontology
Zip code	852-8588
Address	1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan
TEL	+81-95-819-7683
Email	matsuurat@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Matsuura
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Periodontology and Endodontology
Zip code	852-8588
Address	1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan
TEL	+81-95-819-7683
Homepage URL
Email	matsuurat@nagasaki-u.ac.jp

Sponsor
Institute	Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization	Japanese Dental Science Federation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences
Address	1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan
Tel	+81-95-819-7683
Email	matsuurat@nagasaki-u.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 12 Month 24 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	Terminated
Date of protocol fixation	2020 Year 12 Month 24 Day
Date of IRB	2020 Year 12 Month 24 Day
Anticipated trial start date	2020 Year 12 Month 24 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Randomized clinical trials which evaluate the effectiveness of calcium silicate-based materials used for non-surgical root canal treatment in mature permanent teeth will be searched and included in this systematic review and meta-analysis. An electronic search will be performed in the following four databases: PubMed, The Cochrane Library, Scopus and ProQuest. The search will be performed on 24 December 2020. In addition, a manual search will be undertaken on three journals, Journal of Dental Research, International Journal of Endodontics and Journal of Endodontics, published from 2000 to 2020.

Management information
Registered date	2020 Year 12 Month 24 Day
Last modified on	2022 Year 01 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048850