UMIN-CTR Clinical Trial

Basic information
Public title	Effects of sonic and manual toothbrushes applied for assisted brushing of the disabled on plaque removal efficiency, caregiver burden, and long-term oral hygiene - A randomized, parallel-group study
Acronym	SBDOH
Scientific Title	Effects of sonic and manual toothbrushes applied for assisted brushing of the disabled on plaque removal efficiency, caregiver burden, and long-term oral hygiene - A randomized, parallel-group study
Scientific Title:Acronym	SBDOH
Region	Japan

Condition
Condition	periodontal disease severely handicapped person
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Oral diseases are mainly bacterial infections. Compared to normal people, people with disabilities have poor oral hygiene and a higher incidence of oral diseases such as dental caries and gingivitis. In addition, even if they have oral diseases, they often cannot complain of pain or difficulty in chewing and are found in an advanced state. In order to prevent these diseases, daily brushing is of utmost importance. However, if a person has a strong refusal behavior due to a disability, assisted brushing can be burdensome for the caregiver, making it difficult to maintain adequate oral hygiene. Therefore, this study was conducted to measure the efficiency of plaque removal and the rate of periodontitis inhibition by continuous use of a sonic toothbrush with high bacterial removal efficiency and a manual toothbrush with high bacterial removal accuracy in assisted brushing of patients with disabilities using the conventional indices PlI and GI and the new index PISA. In addition, the changes in the number of bacteria, genome, and In addition, changes in the number of bacteria and changes in the oral flora by genome analysis will be evaluated. In this study, the effects of assisted brushing with a sonic toothbrush on the gingiva of people with disabilities and its clinical effects will be clarified. In addition, the degree of burden on the caregiver will be verified by questionnaire, and an efficient oral cleaning method with less burden for both the patient and the caregiver supporting the patient will be proposed.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	0 weeks and 32 weeks PlI
Key secondary outcomes	0 and 32 weeks: PCR, bacterial count test, periodontal inflammation surface area (PISA), GI, bacterial flora test (next generation sequencing), caregiver burden (questionnaire)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Forty patients with disabilities who regularly visit our department and who have obtained written consent from their guardians will be included. At the time of the regular checkup, the age, sex, type and degree of disability, background disease, and treatment will be transcribed from the medical record. The dentist in charge will evaluate the PCR, PlI, GI, and PISA scores of the patients 1-5 hours after meals and collect dental plaque. The collected plaque will be counted for bacteria using a calisimeter. In addition, a questionnaire regarding the level of burden associated with assisted brushing will be administered to caregivers. The PCR will be assessed every 8 weeks to measure changes in oral hygiene over time. 32 weeks later, the same assessment will be conducted as before the intervention to evaluate changes over time in each group and to assess differences between groups. After 32 weeks, the same assessment will be performed as before the intervention to evaluate the change over time for each group and to evaluate the difference between the groups.
Interventions/Control_2	Forty patients with disabilities who regularly visit our department and who have obtained written consent from their guardians will be included. At the time of the regular checkup, the age, sex, type and degree of disability, background disease, and treatment will be transcribed from the medical record. The dentist in charge will evaluate the PCR, PlI, GI, and PISA scores of the patients 1-5 hours after meals and collect dental plaque. The collected plaque will be counted for bacteria using a calisimeter. In addition, a questionnaire regarding the level of burden associated with assisted brushing will be administered to caregivers. The PCR will be assessed every 8 weeks to measure changes in oral hygiene over time. 32 weeks later, the same assessment will be conducted as before the intervention to evaluate changes over time in each group and to assess differences between groups. After 32 weeks, the same assessment will be performed as before the intervention to evaluate the change over time for each group and to evaluate the difference between the groups.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Age 20 years or older at the time of obtaining consent (2) Adults scheduled for oral hygiene instruction (2) Adults scheduled to receive oral hygiene instruction (3) Those with 20 or more remaining teeth (2) Adults who are scheduled to receive oral hygiene instruction (3) Those who have at least 20 remaining teeth (4) Those who can obtain written consent from a substitute for participation in this study (5) Those with the most severe or severe disability (Hiroshima City Ryoiku Techo (Ryoiku Techo) maruA and A) or those with motor disabilities due to cerebral palsy.
Key exclusion criteria	1) Those with C3 caries (2) Patients taking antibacterial drugs (3) Patients taking antiepileptic drugs or calcium channel blockers that induce gingival proliferation 3) Those who are taking antiepileptic drugs or calcium channel blockers that induce gingival proliferation. 4) Those who cannot brush by a caregiver. (4) Those who cannot brush by a caregiver (5) Others who are deemed inappropriate by the principal investigator or sub-investigator
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoshiyuki Middle name Last name Okada
Organization	Hiroshima University Hospital
Division name	Dentistry for the Disabled
Zip code	734-8551
Address	1-2-3, Kasumi, Minami-ku, Hiroshima City
TEL	082-257-5788
Email	okay@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Chika Middle name Last name Kozono
Organization	Hiroshima University Hospital
Division name	Clinical Support Department, Dental Division
Zip code	734-8551
Address	1-2-3, Kasumi, Minami-ku, Hiroshima City
TEL	082-257-5788
Homepage URL
Email	kozono@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

Funding Source
Organization	Hiroshima 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	Hiroshima University Hospital
Address	1-2-3, Kasumi, Minami-ku, Hiroshima City
Tel	082-257-5788
Email	okay@hiroshima-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 08 Month 25 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	Open public recruiting
Date of protocol fixation	2021 Year 08 Month 23 Day
Date of IRB	2021 Year 08 Month 23 Day
Anticipated trial start date	2021 Year 08 Month 24 Day
Last follow-up date	2027 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	2021 Year 08 Month 24 Day
Last modified on	2021 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051322