UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019147 |
|---|---|
| Receipt number | R000022095 |
| Scientific Title | Effect of Light Activated Disinfection on the Periodontal Treatment |
| Date of disclosure of the study information | 2015/09/29 |
| Last modified on | 2018/04/02 19:15:53 |
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Basic information
Public title
Effect of Light Activated Disinfection on the Periodontal Treatment
Acronym
Effect of Light Activated Disinfection on the Periodontal Treatment
Scientific Title
Effect of Light Activated Disinfection on the Periodontal Treatment
Scientific Title:Acronym
Effect of Light Activated Disinfection on the Periodontal Treatment
Region
| Japan |
Condition
Condition
Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of light activated disinfection for the periodontal treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
probing pocket depth
Key secondary outcomes
bleeding on probing, pus discharge
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Scaring and root planing together with light activated disinfection treatment using Fotosan agent.
Interventions/Control_2
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) Patients having probing pocket depth more than 5mm
Key exclusion criteria
1) Patients who recieved antibiotics
2) Patients who have photoallergy
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Morita |
Organization
Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Preventive Dentistry
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-6712
mmorita@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Morita |
Organization
Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Preventive Dentistry
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-6712
Homepage URL
mmorita@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Preventive Dentistry, Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2015 | Year | 09 | Month | 29 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 29 | Day |
Last modified on
| 2018 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022095
