UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053954 |
|---|---|
| Receipt number | R000061581 |
| Scientific Title | Impact of occlusal contact decreasing in habitual chewing side on masticatory function |
| Date of disclosure of the study information | 2024/03/25 |
| Last modified on | 2025/09/24 08:46:02 |
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Basic information
Public title
Impact of occlusal contact decreasing in habitual chewing side on masticatory function
Acronym
Impact of occlusal contact decrease in HCS on mastication
Scientific Title
Impact of occlusal contact decreasing in habitual chewing side on masticatory function
Scientific Title:Acronym
Impact of occlusal contact decrease in HCS on mastication
Region
| Japan |
Condition
Condition
Tooth loss
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For participants with sound dentition, a mastication assessment will be performed after applying an occlusal splint without occlusal contacts in the unilateral molar region. Subjective and objective masticatory ability will be compared between the following two conditions: lack of occlusal contacts in i) the habitual chewing side and ii) the non-habitual chewing side.
Basic objectives2
Others
Basic objectives -Others
Clinical impact on oral function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Masticatory ability
Key secondary outcomes
Maximum occlusal force
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Having sound dentition
Key exclusion criteria
History of premolar extraction for orthodontic therapy
Having tooth contact with the third molar
Having teeth with severe crown defect or periodontal disease
Severe malocclusion
Revealing subjective masticatory disturbance
Unclear habitual chewing side
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Junichio |
| Middle name | |
| Last name | Wada |
Organization
Tokyo Dental and Medical University (TMDU)
Division name
Advanced Prosthodontics
Zip code
1138510
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
0358035515
wadajun.rpro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Wada |
Organization
Tokyo Dental and Medical University (TMDU)
Division name
Advanced Prosthodontics
Zip code
1138510
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
0358035515
Homepage URL
wadajun.rpro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University (TMDU)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University (TMDU)
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
Tel
0358035515
wadajun.rpro@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
| 2024 | Year | 03 | 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
28
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
| 2024 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
Experimental occlusal splints will be applied to participants with sound dentitions to represent the experimental condition without occlusal contacts in the unilateral molar region.
For each participant, occlusal splints with the following conditions will be fabricated: a lack of occlusal contacts in the molar region on i) the habitual chewing side and ii) the non-habitual chewing side.
Subjective and objective masticatory ability will be assessed.
The masticatory ability will be compared among the experimental conditions with a lack of occlusal contacts in the molar region on i) the habitual chewing side and ii) the non-habitual chewing side.
Management information
Registered date
| 2024 | Year | 03 | Month | 23 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061581
