UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035651 |
|---|---|
| Receipt number | R000040595 |
| Scientific Title | The evaluation of satisfaction and masticatory efficiency after making full denture |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2026/07/30 10:32:09 |
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Basic information
Public title
The evaluation of satisfaction and masticatory efficiency after making full denture
Acronym
The evaluation of satisfaction and masticatory efficiency after making full denture
Scientific Title
The evaluation of satisfaction and masticatory efficiency after making full denture
Scientific Title:Acronym
The evaluation of satisfaction and masticatory efficiency after making full denture
Region
| Japan |
Condition
Condition
edentulous jaw
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Perform a prospective cohort study about the satisfaction of the patient before and after the new denture manufacture and the change of the examination of chewing function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
masticatory function test
Key secondary outcomes
toungue pressure
qiestionnaire
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 not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver | Other |
Interventions/Control_1
making the full denture
Interventions/Control_2
not making the full denture
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient of the full denture
Key exclusion criteria
patient of mutual fdifficult understanding
patient of moving
patient of swallowing difficulty
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Inoue |
Organization
Clinical Dentistry, Tokushima University Guraduate School
Division name
Department of Stomatgnathic Function and Occlusal Reconstruction
Zip code
7708504
Address
3-18-15 Kuramoto-Cho, Tokushim city
TEL
0886337350
inoue.miho@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Inoue |
Organization
Clinical Dentistry, Tokushima University Guraduate School
Division name
Department of Stomatgnathic Function and Occlusal Reconstruction
Zip code
7708504
Address
3-18-15 Kuramoto-Cho, Tokushim city
TEL
0886337350
Homepage URL
inoue.miho@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University
Address
3-18-15 Kuramoto-cho, Tokushima-city
Tel
0886337350
inoue.miho@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
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
nothing
Publication of results
Unpublished
Result
URL related to results and publications
nothing
Number of participants that the trial has enrolled
30
Results
1, The edible food questionnaire: significant differences were found between before fabrication(fab) and 3 months.
2, The check-gum: scores were significantly higher between before fab and 1 month, and 3 months.
3, Masticatory function using gummy jelly: glucose elution was significantly increased between before fab and 3 months.
4,Tongue pressure test : Values were significantly increased between before fab and 3 months.
5, Oral health-related QOL: scores were significantly decreased.
Results date posted
| 2026 | Year | 07 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants (Fabrication Group): Eighteen patients (6 men, 12 women) attending the Department of Dentistry at Tokushima University Hospital who were newly fabricated complete dentures (mean age 76.5 years, range 53-89). By denture type: 6 patients with bimaxillary complete dentures (FD/FD), 8 with a maxillary complete denture and mandibular partial denture (FD upper/PD lower), 3 with a maxillary complete denture only, and 1 with a maxillary partial denture and mandibular complete denture (PD upper/FD lower).
Control Group: Twelve outpatients who were not having dentures fabricated (5 men, 7 women), mean age 76.67 years (range 61-86). By denture type: 5 patients with bimaxillary complete dentures (FD/FD), 2 with a maxillary complete denture and mandibular partial denture (FD upper/PD lower), 1 with a maxillary complete denture only, and 4 with a maxillary partial denture and mandibular complete denture (PD upper/FD lower).
Participant flow
The study explained to patients the purpose of investigating the association between satisfaction and masticatory function after fabrication of complete dentures, and evaluations were performed on patients who provided informed consent. These evaluations included a questionnaire based on the Hirai-type Edible Food Analysis Sheet, the xylitol chewing check-gum (Lotte), a masticatory function test using gummy jelly (GC), a tongue pressure test using a tongue pressure measuring device (JMS), the revised OHIP (Table 2), and a psychiatric condition assessment questionnaire. Assessments were performed three times in the fabrication group: the first at the time of obtaining consent, the second at 1 month after fabrication, and the third at 3 months after fabrication. In the control group, assessments were performed twice: the first at the time of obtaining consent and the second at 6 months later. Even after providing consent, patients were free to modify or withdraw their participation at any time.
Adverse events
Nothing
Outcome measures
1, Questionnaire based on the Hirai-type Edible Food Analysis Sheet
2, Xylitol chewing check-gum (Lotte)
3, Masticatory function test using gummy jelly (GC)
4, Tongue pressure test using a tongue pressure measuring device (JMS)
5, Evaluation using the revised OHIP (Table 2) and the psychiatric condition assessment questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040595
