UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052476 |
|---|---|
| Receipt number | R000059600 |
| Scientific Title | Research on oral functions of cleft lip and palate patients |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2023/12/26 16:38:06 |
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Basic information
Public title
Research on oral functions of cleft lip and palate patients
Acronym
Research on oral functions of cleft lip and palate patients
Scientific Title
Research on oral functions of cleft lip and palate patients
Scientific Title:Acronym
Research on oral functions of cleft lip and palate patients
Region
| Japan |
Condition
Condition
Cleft lip,Cleft lip and jaw,Cleft lip and palate,Cleft palate
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure oral function in patients with cleft lip and cleft palate, to obtain standard values for each age group, and to examine the relationship with morphology and to identify its characteristics.
Basic objectives2
Others
Basic objectives -Others
Cleft lip and palate patients have been treated with cleft lip and palate surgery, palatoplasty, and orthodontic treatment to restore their morphology, but the extent to which this restoration of morphology is related to oral function remains unclear.
In this study, we focused on the oral functions of cleft lip and cleft palate patients and clarified the relationship between these functions and morphology.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lip closure strength
Key secondary outcomes
Tongue pressure
Chewing efficiency
Evaluation of occlusion
Facial soft tissue morphology
Maxillofacial skeletal morphology evaluation
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
| 5 | years-old | <= |
Age-upper limit
| 13 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Disease name:Cleft lip,Cleft lip and jaw,Cleft lip and palate,Cleft palate
(2)Age: 5 years old or older, 13 years old or younger
(3) Gender: Male and female
(4) Those who have obtained written consent on behalf of their guardians for research participation.
Key exclusion criteria
(1)Patients with other congenital abnormalities
(2)Other patients deemed inappropriate by the research director
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | kaoru |
| Middle name | |
| Last name | igarashi |
Organization
Tohoku University Graduate of Dentistry
Division name
Craniofacial Anomalies
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi Prefecture
TEL
022-717-8379
igarashi@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | kasumi |
| Middle name | |
| Last name | hasegawa |
Organization
Tohoku University Graduate of Dentistry
Division name
Craniofacial Anomalies
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi Prefecture
TEL
022-7171-8379
Homepage URL
kawamura.kasumi.p4@dc.tohoku.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
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
Tohoku University Graduate of Dentistry
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi Prefecture
Tel
0227178379
kawamura.kasumi.p4@dc.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 31 | 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
| 2023 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
research design
: Cross-sectional study
Target audience
:Among patients attending Tohoku University Hospital Department of Oral and Maxillofacial Functional Treatment, men and women aged 5 years and under 13 with cleft lip, cleft lip and jaw, cleft lip and palate, or cleft palate or above.
Measurement item
:1. Oral function test (1) Lip pressure (2) Tongue pressure (3) Mastication efficiency
2. Morphological evaluation (1) Occlusal evaluation (2) Facial soft tissue morphology (3) Maxillofacial skeletal morphology
Management information
Registered date
| 2023 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059600
| Research Plan | |
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| Research case data | |
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