UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010753 |
|---|---|
| Receipt number | R000011887 |
| Scientific Title | Application of dental LASER to periodontal tissue regenerative therapy |
| Date of disclosure of the study information | 2013/05/20 |
| Last modified on | 2013/12/26 21:05:56 |
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Basic information
Public title
Application of dental LASER to
periodontal tissue regenerative therapy
Acronym
Application of dental LASER to
periodontal tissue regenerative therapy
Scientific Title
Application of dental LASER to
periodontal tissue regenerative therapy
Scientific Title:Acronym
Application of dental LASER to
periodontal tissue regenerative therapy
Region
| Japan |
Condition
Condition
chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the effect of LASER on periodontal
tissue regenerative therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plaque Index
Probing Depth
Clinical Attachment Level
Gingival Index
Gingival Recession
Alveolar Bone Height
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Periodontal regenerative therapy using the enamel matrix protein
Interventions/Control_2
Irradiate the dental laser for promote an anagenesis with periodontal regenerative therapy using the enamel matrix protein.
Interventions/Control_3
control
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 of chronic periodontitis who have 3 or more blocks which is indicated periodontal regenerative therapy after initial preparation
2) Patients who can give informed consent themselves in writing
Key exclusion criteria
1) Patients with any systemic disease known to affect the outcomes of periodontal regenerative therapy
2) Patient that laser irradiation is contraindicated
3) Patients who have smoking habit
4) Other (doctors dicision)
Target sample size
100
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
0263-51-2015
yoshinari@po.mdu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miki Manabu |
Organization
Matsumoto dental university school of dentistry
Division name
department of periodontology
Zip code
Address
1780 Gobara Hirooka Shiojiri Nagano Japan
TEL
0263-51-2016
Homepage URL
mk_mnb@po.mdu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 20 | 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
| 2013 | Year | 05 | Month | 17 | Day |
Last modified on
| 2013 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011887
