UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032452 |
|---|---|
| Receipt number | R000037007 |
| Scientific Title | Establishment of new rehabilitation for jaw deformity patients using masticatory training food. |
| Date of disclosure of the study information | 2018/05/02 |
| Last modified on | 2022/11/09 18:18:18 |
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Basic information
Public title
Establishment of new rehabilitation for jaw deformity patients using masticatory training food.
Acronym
Establishment of new rehabilitation using masticatory training food.
Scientific Title
Establishment of new rehabilitation for jaw deformity patients using masticatory training food.
Scientific Title:Acronym
Establishment of new rehabilitation using masticatory training food.
Region
| Japan |
Condition
Condition
Jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of new rehabilitation using masticatory training food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activity Index
Key secondary outcomes
Asymmetry Index of muscle activity
Error Index
Maximal occlusal force
Survey
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
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Early Training group
from current study approval day to March, 2023
Interventions/Control_2
Late Training group
from April, 2016 to March, 2023
Interventions/Control_3
Non-Training group
from January, 2011 to February, 2018
Interventions/Control_4
Normal occlusion group
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 17 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Early Training group : 35 patients of jaw deformities (forward in tervention study) treated surgical orthognathic in Tokushima university hospital from current study approval day to March, 2023.
Late Training group : 35 patients of jaw deformities (backward investigation) treated surgical orthognathic and masticatory exercise using chewing gum from April, 2016 to March, 2023 in Tokushima univercity hospital of the diagnosis of jaw deformities.
Non-training group : 35 patients of jaw deformities (forward in tervention study) treated surgical orthognathic in Tokushima university hospital from January, 2011 to February, 2018.
Normal occlusion group : Among trust students performing a bedside teaching in this school student, staff and senior Popes, it is 35 individual normal occlusion people.
Key exclusion criteria
Training group, non-training group
1 Chin transformation symptom patient due to inborn character abnormality.
2 The patient who has a symptom to temporomandibular joint.
3 The patient who has a symptom to Hyposalivation.
4 The patient who has a symptom to Swallowing dysfunction.
Normal occlusion group
1 It is a person with the disharmony for the relations between the chin.
2 Person having the prosthesis that cuspid, molar tooth relations coat crowding, tooth missing, cusp in other than I grade and top and bottom dentition.
3 It is a person with the experience of the correction treatment in the past.
4 The patient who has a symptom to Hyposalivation.
5 The patient who has a symptom to Swallowing dysfunction.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Horiuchi |
| Middle name | |
| Last name | Shinya |
Organization
Tokushima univercity
Division name
Department of Orthodontics and dentofacial orthopedics, institute of biomedical science
Zip code
7708504
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-7357
horiu@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tanaka |
| Middle name | |
| Last name | Eiji |
Organization
Tokushima univercity
Division name
Department of Orthodontics and dentofacial orthopedics, institute of biomedical science
Zip code
7708504
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-7357
Homepage URL
etanaka@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima univercity
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
Tokushima univercity
Address
2-50-1 kuramoto, Tokushima 770-8503, Japan
Tel
088-633-9294
awachiken@tokushima-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
| 2018 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S1991790221002932?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1991790221002932?via%3Dihub
Number of participants that the trial has enrolled
18
Results
Compared with the non-training group, the training group showed a trend toward greater recovery amount of the maximum bite force from just orthognathic surgery (Pre) to 3 months after surgery (T3), and a significantly greater recovery amount in the masticatory performance (MP) (p < 0.05) from Pre to T3. When the time-series change of MP was evaluated in both groups from 10 days after surgery to T3, a significant difference was observed in the interaction terms (p = 0.03).
Results date posted
| 2022 | Year | 11 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 07 | Month | 01 | Day |
Baseline Characteristics
Twelve patients with non-syndromic mandibular prognathism were recruited into this study. All the patients underwent orthognathic surgery at the Tokushima University Hospital. The training group consisted of five patients who received the rehabilitation program after surgery and the non- training group consisted of seven patients who did not receive the rehabilitation program. Six healthy individuals were enrolled as the control group. The control group comprised dental school students and staff members at Tokushima University.
Participant flow
Of the 12 patients who underwent orthognathic surgery, this study sample consisted of 5 patients in the training group and 4 patients in the non-training group that were recorded the maximum bite force and the masticatory performance throughout the experimental period. In total, 3 patients in the non-training group were excluded because their records did not complete due to the spread of COVID-19.
Adverse events
Outcome measures
The effects were assessed by determining the maximum bite force and the masticatory performance. Clinical assessments were performed just before orthognathic surgery and at 10 days, 1 month, 2 months, and 3 months after surgery.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 02 | Day |
Last modified on
| 2022 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037007
