UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032384
Receipt number 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 12:24:07

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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 or person

Institute

Comprehensive Conservation Dentistry Gerodontology,Hokkaidou University Hospital.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036919


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name