UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058280 |
|---|---|
| Receipt number | R000066627 |
| Scientific Title | Analysis of food texture suitable for presurgical orthodontic treatment in patients' diet. |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/06/25 22:00:45 |
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Basic information
Public title
Analysis of food texture suitable for presurgical orthodontic treatment in patients' diet.
Acronym
Analysis of food texture suitable for presurgical orthodontic treatment in patients' diet.
Scientific Title
Analysis of food texture suitable for presurgical orthodontic treatment in patients' diet.
Scientific Title:Acronym
Analysis of food texture suitable for presurgical orthodontic treatment in patients' diet.
Region
| Japan |
Condition
Condition
jaw deformities
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify suitable food hardness for patients undergoing presurgical orthodontic treatment by testing masticatory function with five different hardness gummies.
Basic objectives2
Others
Basic objectives -Others
There are various types of occlusion such as normal occlusion, maxillary protrusion, mandibular protrusion, and facial asymmetry, and there should be appropriate food properties and hardness for each occlusion. However, there have been no study on the appropriate food properties for different occlusion of patients undergoing presurgical orthodontic treatment. The purpose of this study is to clarify appropriate food properties for each occlusion in patients undergoing presurgical orthodontic treatment, based on masticatory movement data of test gummy bears of different hardness. By clarifying the above, it is expected to lead to the selection of foods suitable for each type of occlusion and the optimization of food properties during presurgical orthodontic treatment, and to a better dietary life.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of masticatory cycle time.
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Parallel
Chewing of test gummies will be used as intervention in 6 groups: malocclusion with nonsurgical orthodontic treatment (maxillary protrusion, mandibular protrusion, facial asymmetry) and malocclusion with surgical orthodontic treatment (maxillary protrusion, mandibular protrusion, facial asymmetry).
The amount of intervention will be 30 chews each of the 5 different hardness gummy bears, all of which will be spit out after the test. The number of interventions is one.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Malocclusion with nonsurgical orthodontic treatment (maxillary protrusion, mandibular protrusion, facial asymmetry) and malocclusion with surgical orthodontic treatment (maxillary protrusion, mandibular protrusion, facial asymmetry). Age is 15 years older. Gender is both male and female.
Key exclusion criteria
(1) Cases with missing teeth other than third molars
(2) Cases in which communication is difficult.
(3) Cases in which participation in this study is deemed difficult by principal investigator or research coordinator.
(4) Patients who are allergic to gelatin.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Kanetaka |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of orthodontics and dentofacial orthopedics
Zip code
980-8575
Address
4-1 Seiryo-machi, Aobaku, Sendai
TEL
0227178374
hiroyasu.kanetaka.e6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mikoto |
| Middle name | |
| Last name | Mori |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of orthodontics and dentofacial orthopedics
Zip code
980-8575
Address
4-1 Seiryo-machi, Aobaku, Sendai
TEL
0227178374
Homepage URL
mikoto.mori.b2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
No research funding organization.
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
Ethics Committee Tohoku University Graduate School of Dentistry
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575
Tel
022-717-8244
den-syom@grp.tohoku.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066627
