UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000032384
Receipt No. R000036919
Scientific Title A Study of the Usefulness of oral Mucosal Massage for Oral Dryness of Patients with Schizophrenia.Unbilinding randaom test.
Date of disclosure of the study information 2018/04/26
Last modified on 2020/10/29 (Ver. 4)

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Basic information
Public title A Study of the Usefulness of oral Mucosal Massage for Oral Dryness of Patients with Schizophrenia.Unbilinding randaom test.
Acronym Effect of Oral Mucosal Massage on Oral Dryness of Patients with Schizophrenia.
Scientific Title A Study of the Usefulness of oral Mucosal Massage for Oral Dryness of Patients with Schizophrenia.Unbilinding randaom test.
Scientific Title:Acronym Effect of Oral Mucosal Massage on Oral Dryness of Patients with Schizophrenia.
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether oral mucosal massage is effective for mouth drying, which is an adverse reaction of antipsychotics, for patients with schizophrenia with dry mouth.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mouth moisture measurement value
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 We allocate to two groups of oral mucosal massage group (oral mucosal massage + conventional oral care) and oral care group (conventional oral care only).
To the oral mucosal massage group, the dentist instructs the oral mucosal massage and the research begins after the research subject acquires the operation ceremony. The oral mucosal massage group performs oral mucosal massage every day, and has oral care that the patient himself has been enforcing by the original toothbrush etc. is continued. Every two weeks thereafter, the dentist confirms whether the oral mucosal massage is performed properly with the correct technique for the subject, and if it is inappropriate, it will be instructed again.
Interventions/Control_2 The oral care group is asked to continue the oral care that the person himself had been enforcing by the conventional toothbrush etc.
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: Persons whose age is 20 years or older at the time of consent acquisition
2: Persons who have classification of Kakinoki 1 degree or more, which is the clinical diagnostic criteria for dry mouth
3: After receiving sufficient explanation for participation in this research, those who gained consent by free will of the research subject person with sufficient understanding
4: The degree of symptoms of schizophrenia is from the chronic phase to the recovery phase
Key exclusion criteria 1: There are complications of other central nervous system diseases
2: Persons who have history of substance dependency / abuse such as alcohol
3: Persons with past mental development delay or dementia
4: Those who have been diagnosed with dry mouth disease, Sjogren's syndrome, sleep apnea syndrome
5:Persons who are suspected of dry mouth by drugs other than antipsychotics
6: Others who judged that the research director is inappropriate as the research subject
Target sample size 46

Research contact person
Name of lead principal investigator
1st name Takae
Middle name
Last name Abe
Organization Hokkaidou University Hospital
Division name Comprehensive Conservation Dentistry Gerodontology
Zip code 060-8586
Address Sapporo City Kita-ku North 13, West 7th Street
TEL 0117064582
Email tkea-224@den.hokudai.ac.jp

Public contact
Name of contact person
1st name Takae
Middle name
Last name Abe
Organization Hokkaidou University Hospital
Division name Comprehensive Conservation Dentistry Gerodontology
Zip code 060-8586
Address Sapporo City Kita-ku North 13, West 7th Street
TEL 0117064582
Homepage URL
Email tkea-224@den.hokudai.ac.jp

Sponsor
Institute Comprehensive Conservation Dentistry Gerodontology,Hokkaidou University Hospital.
Institute
Department

Funding Source
Organization Hokkaidou University Hospital.
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 Hokkaidou University Hospital.
Address Sapporo City Kita-ku North 13, West 7th Street
Tel 0117064582
Email tkea-224@den.hokudai.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 啓生会病院（北海道）

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 26 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 36
Results 
 It was suggested that salivary gland / oral mucosal massage may promote increased salivary secretion in patients with chronic schizophrenia. In addition, it was suggested that oral administration of typical antipsychotics inhibited the effect of salivary gland / oral mucosal massage, and that levomepromazine was the main inhibitor of typical antipsychotics.
Results date posted
2020 Year 10 Month 29 Day
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 Completed
Date of protocol fixation
2018 Year 04 Month 24 Day
Date of IRB
2018 Year 03 Month 24 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 25 Day
Last modified on
2020 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036919