UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007325 |
|---|---|
| Receipt number | R000008623 |
| Scientific Title | The Effect of Gingival Melanin Depigmentaion by Dental Lazer Treatment. |
| Date of disclosure of the study information | 2012/02/18 |
| Last modified on | 2012/02/18 10:12:29 |
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Basic information
Public title
The Effect of Gingival Melanin Depigmentaion by Dental Lazer Treatment.
Acronym
The Effect of Gingival Melanin Depigmentaion by Dental Lazer Treatment.
Scientific Title
The Effect of Gingival Melanin Depigmentaion by Dental Lazer Treatment.
Scientific Title:Acronym
The Effect of Gingival Melanin Depigmentaion by Dental Lazer Treatment.
Region
| Japan |
Condition
Condition
Gingival Melanin Depigmentaion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There have been reported several methods to remove gingival hyperpigmentation, but, only a few reports are exist about comparing the effect of each method. Therefore, we will evaluate the effects both Er: YAG laser and CO2 laser treatment for gingival depigmentation numerically.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The hyperpigmentation area is put into 4 parts. Each part of the gingiva is treated as follows. Er:YAG laser: maxillary, left side, central incisor-cuspid, CO2 laser: mandibular, right side, central incisor-cuspid, abrasion surgery by carborundum points: maxillary, right side, central incisor-cuspid, and without treatment (as a control): mandibular, left side, central incisor-cuspid. The irradiation is carried out accoding to the manual for the hyperpigmentation. After treatment, the depigmentation effects will be evaluated by using Image J (ver1.43, NIH, Bethesda) about all methods.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The hyperpigmentation area is put into 4 parts. Each part of the gingiva is treated as follows. Er:YAG laser: maxillary, left side, central incisor-cuspid, CO2 laser: mandibular, right side, central incisor-cuspid, abrasion surgery by carborundum points: maxillary, right side, central incisor-cuspid, and without treatment (as a control): mandibular, left side, central incisor-cuspid. The irradiation is carried out accoding to the manual for the hyperpigmentation.
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
Smorker
Key exclusion criteria
Non-smokers
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuo Yoshinari |
Organization
Matsumoto dental university school of dentistry
Division name
department of periodontology
Zip code
Address
1780 gobara hirooka shiojiri nagano Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eisaku Nishida |
Organization
Matsumoto dental university school of dentistry
Division name
department of periodontology
Zip code
Address
1780 gobara hirooka shiojiri nagano Japan
TEL
Homepage URL
Sponsor or person
Institute
Matsumoto dental university
Institute
Department
Personal name
Funding Source
Organization
Matsumoto dental university
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
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
松本歯科大学病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 18 | 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
| 2012 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
| 2012 | Year | 02 | Month | 18 | Day |
Last modified on
| 2012 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008623
