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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046091
Receipt No. R000052596
Scientific Title Evaluation of the usefulness of Mondamin procare alpha as a mouthwash during perioperative management
Date of disclosure of the study information 2021/11/17
Last modified on 2021/11/17

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Basic information
Public title Evaluation of the usefulness of Mondamin procare alpha as a mouthwash during perioperative management
Acronym Evaluation of the usefulness of Mondamin procare alpha as a mouthwash during perioperative management
Scientific Title Evaluation of the usefulness of Mondamin procare alpha as a mouthwash during perioperative management
Scientific Title:Acronym Evaluation of the usefulness of Mondamin procare alpha as a mouthwash during perioperative management
Region
Japan

Condition
Condition preoperative management for oral and maxillofacial surgery
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Perioperative oral management is important for the prevention of ound infections, oral mucositis and secondary infections, caries and periodontitis. In addition, since it is the entrance to the digestive tract, it is very important from the viewpoint of nutritional management. Especially, patients undergoing radiation therapy or intermaxillary fixation have difficulty in mechanically removing plaque by oral cleaning and are prone to these complications. The purpose of this study is to clarify the effect on perioperative oral management using Mondamine procare alpha, which has been reported to be highly effective in chemically removing plaque as a mouthwash.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes oral bacterial counts
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 mouthwash by Mondamine procare alphah that does not contain active ingredients:4 times a day
Interventions/Control_2 mouthwash by Mondamine procare alpha:4 times a day
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients undergoing preoperative radiation therapy for oral cancer
2.Patients requiring intermaxillary fixation due to orthognathic surgery or maxillofacial fracture
Key exclusion criteria 1. Patients with marked malnutrition before the start of treatment (Alb: 2.5 g / dL or less)
2. Patients who have difficulty in gargle on their own.
3. Patients whose doctor deems inappropriate to participate in the study
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Yoshio
Middle name
Last name Yamashita
Organization Saga University
Division name Faculty of Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2397
Email yamashy2@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Reona
Middle name
Last name Aijima
Organization Saga University
Division name Faculty of Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2397
Homepage URL
Email f8197@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

Funding Source
Organization Saga University
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 Clinical Research Center, Saga University Hospital
Address 5-1-1 Nabeshima, Saga
Tel 0952-34-3400
Email kenkyu-shinsei@ml.cc.saga-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
2021 Year 11 Month 17 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 Enrolling by invitation
Date of protocol fixation
2019 Year 10 Month 07 Day
Date of IRB
2019 Year 10 Month 07 Day
Anticipated trial start date
2019 Year 10 Month 07 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

Other
Other related information

Management information
Registered date
2021 Year 11 Month 17 Day
Last modified on
2021 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052596

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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