UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041028 |
|---|---|
| Receipt number | R000046854 |
| Scientific Title | Prospective observational study using restorative materials for root caries |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2022/07/11 17:19:41 |
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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
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
m.inokoshi.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046854
