UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021513 |
|---|---|
| Receipt number | R000024805 |
| Scientific Title | A comparison of the effects of lip trainer devices and sonic toothbrushes on salivary flow and periodontal parameters in older Japanese patients: a randomized controlled clinical trial. |
| Date of disclosure of the study information | 2016/03/17 |
| Last modified on | 2016/03/17 13:35:43 |
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Basic information
Public title
A comparison of the effects of lip trainer devices and sonic toothbrushes on salivary flow and periodontal parameters in older Japanese patients: a randomized controlled clinical trial.
Acronym
Effect of lip trainer and sonic tooth brush on saliva flow and periodontal parameters in elderly Japanese patients.
Scientific Title
A comparison of the effects of lip trainer devices and sonic toothbrushes on salivary flow and periodontal parameters in older Japanese patients: a randomized controlled clinical trial.
Scientific Title:Acronym
Effect of lip trainer and sonic tooth brush on saliva flow and periodontal parameters in elderly Japanese patients.
Region
| Japan |
Condition
Condition
Oral dryness sensation.
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Saliva flow and oral wetness enhancement.
Monitering periodontal parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in oral wetness i.e. Wettability.
Maintainence of periodontal parameters.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Lip trainer device, Patakara®.
Interventions/Control_2
Sonicare®, Sonic electric tooth brush.
Interventions/Control_3
Control, no interventions.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
60 years old and above.
20 or more teeth in oral cavity.
Good systemic health.
Willing to participate in trial.
Key exclusion criteria
Sjögren's syndrome.
Smokers.
Unmotivated patients.
On medications that affect salivary flow.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Murtaza Saleem |
Organization
Matsumoto Dental University
Division name
Oral Health Promotions
Zip code
Address
Hirooka Gobara 1780, Shiojiri city, Nagano
TEL
+81-236-51-2016
murtazads@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Murtaza Saleem |
Organization
Matsumoto Dental University
Division name
Oral Health Promotions
Zip code
Address
Hirooka Gobara 1780, Shiojiri City, Nagano
TEL
+81-263-51-2016
Homepage URL
murtazads@hotmail.com
Sponsor or person
Institute
No sponsors.
Institute
Department
Personal name
Funding Source
Organization
Research Funding for Longevity Science (22-2) from National Center for Geriatrics and Gerontology.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | 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
Wettability was slightly but significantly improve by using Lip Trainer Device.
Non significant improvement of wettability by sonic tooth brush.
Periodontal parameters were maintained by Lip trainer device use.
Sonic tooth brush improved CAL and BOP of periodontal parameters.
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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 22 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 03 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 16 | Day |
Other
Other related information
No adverse effects of using these devices for elderly japanese people were seen.
It coould be helpful of elderly people with oral dryness sensation.
Management information
Registered date
| 2016 | Year | 03 | Month | 17 | Day |
Last modified on
| 2016 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024805
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
