UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053676 |
|---|---|
| Receipt number | R000061254 |
| Scientific Title | Evaluation of genomic instability and genotoxicity with the use of fixed orthodontic appliances and folic acid intake |
| Date of disclosure of the study information | 2024/02/21 |
| Last modified on | 2024/02/21 16:08:24 |
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Basic information
Public title
Genotoxicity with the use of fixed orthodontic appliances and folic acid
Acronym
Genotoxicity with the use of fixed orthodontic appliances and folic acid
Scientific Title
Evaluation of genomic instability and genotoxicity with the use of fixed orthodontic appliances and folic acid intake
Scientific Title:Acronym
Evaluation of genomic instability and genotoxicity with the use of fixed orthodontic appliances and folic acid intake
Region
| North America |
Condition
Condition
Healthy teenagers and adults
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the frequency of genotoxicity and cytotoxicity biomarkers in a control group, a group with orthodontic fixed metal appliances, and a group with orthodontic fixed metal appliances and folic acid intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of micronuclei and nuclear abnormalities in patients with orthodontic fixed appliances and folic acid intake
Key secondary outcomes
Frequency of micronuclei and nuclear abnormalities in three groups: control, patients with orthodontic fixed appliances, and patients with orthodontic fixed appliances and folic acid intake in a six-month period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Group III: Orthodontic fixed appliances and folic acid intake
Administration: 400 mcg DFE (dietary folate equivalents)/day/three months
Interventions/Control_2
Group I: Control
No intervention
Interventions/Control_3
Group I: Orthodontic fixed appliances
No intervention
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet the criteria of:
1. Need of orthodontic treatment
2. Non-smoking
3. No oral or systemic diseases
4. Without metal restorations or oral prostheses
5. Clinically healthy oral mucosa
6. No prior orthodontic treatment
7. No occupational exposure to metals
8. Not receiving medications or supplements
9. No known allergies to jewelry, watches or sources of nickel and chromium
Key exclusion criteria
1. Pregnant women
2. Patients with cancer or taking antineoplastics
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | David |
| Middle name | |
| Last name | Bautista Martinez |
Organization
Autonomous University State of Mexico (UAEMex)
Division name
Orthodontics department
Zip code
50130
Address
Paseo Tollocan, Universidad, Toluca de Lerdo, Mexico
TEL
+527222179070
dr.david.bautista@gmail.com
Public contact
Name of contact person
| 1st name | David |
| Middle name | |
| Last name | Bautista Martinez |
Organization
Autonomous University State of Mexico (UAEMex)
Division name
Orthodontics department
Zip code
50130
Address
Paseo Tollocan, Universidad, Toluca de Lerdo, Mexico
TEL
+527222179070
Homepage URL
dr.david.bautista@gmail.com
Sponsor or person
Institute
Center for Research and Advanced Studies in Dentistry "Dr. Keisaburo Miyata" (C.I.E.A.O.), Faculty of Dentistry, UAEMex
Institute
Department
Personal name
Funding Source
Organization
None
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 School of Dentistry, Autonomous University State of Mexico (UAEMex), Toluca, Mexico
Address
Paseo Tollocan, Universidad, Toluca de Lerdo, Mexico
Tel
+527222179070
cieao@uaemex.mx
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
| 2024 | Year | 02 | Month | 21 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 21 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061254
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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