UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048365 |
|---|---|
| Receipt number | R000055109 |
| Scientific Title | A prospective observational study on the effect of oral function and feeding status on salivary bacterial counts in oral surgery patients |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2024/07/16 16:27:18 |
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Basic information
Public title
A prospective observational study on the effect of oral function and feeding status on salivary bacterial counts in oral surgery patients
Acronym
Relationship between Oral Function and Eating Condition and Salivary Bacterial Counts in Oral Surgery Patients
Scientific Title
A prospective observational study on the effect of oral function and feeding status on salivary bacterial counts in oral surgery patients
Scientific Title:Acronym
Relationship between Oral Function and Eating Condition and Salivary Bacterial Counts in Oral Surgery Patients
Region
| Japan |
Condition
Condition
Oral Surgical Disease
Classification by specialty
| Oral surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To measure oral function and salivary bacterial counts before and after oral surgery to identify risk factors for increased bacterial counts.
Basic objectives2
Others
Basic objectives -Others
To explore the factors related to the number of bacteria in saliva.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre- and postoperative bacterial counts in saliva
Key secondary outcomes
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
1. Patients who will undergo partial tongue resection or maxilla- and mandibulectomy under general anesthesia at the Department of Oral and Maxillofacial Surgery of Nagasaki University Hospital. (including the first occurrence and recurrence of the disease).
2. Patients must be 20 years of age or older at the time of diagnosis.
Key exclusion criteria
1. patients managed with postoperative endotracheal intubation (both oral and nasal intubation and tracheostomy)
2. patients with no wound in the oral cavity (e.g., for neck dissection only)
3. patients who are able to take oral food the next day, such as those who have undergone a tooth extraction or a mandibular cystectomy.
4. patients with cognitive problems that prevent them from performing oral function tests.
5. patients who are allergic to chewing gummies.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University Graduate School of Biomedical Science
Division name
Department of Oral Health
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197698
sakiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Oral Health
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
+81958197698
Homepage URL
sakiko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
The Institutional Review Board (IRB) of Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
| 2022 | Year | 07 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055109
