UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031642 |
|---|---|
| Receipt number | R000035827 |
| Scientific Title | Application of Er:YAG laser in the treatment of periodontal pockets with intrabony defects |
| Date of disclosure of the study information | 2018/03/16 |
| Last modified on | 2021/09/17 14:01:09 |
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Basic information
Public title
Application of Er:YAG laser in the treatment of periodontal pockets with intrabony defects
Acronym
Er:YAG laser treatment of periodontal pockets
Scientific Title
Application of Er:YAG laser in the treatment of periodontal pockets with intrabony defects
Scientific Title:Acronym
Er:YAG laser treatment of periodontal pockets
Region
| Japan |
Condition
Condition
Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of combination therapy of SRP and Er:YAG laser treatment in periodotal pockets with intrabony defects compared to SRP alone by randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical Attachment Level (CAL) at 1 and 2 weeks and 1, 3 , 6 and 12 months after treatment.
Key secondary outcomes
Proving pocket depth (PPD), Gingival recession, tooth mobility, Bleeding on Probing (BOP), Plaque Index(PI), Gingival Index (GI), total number of periodontal bacteria (P.gingivalis, T. forsythia, T. denticola) and IL-1b level in gingival crevicular fluid at 1 and 2 weeks and 1, 3, 6 and 12 months after treatment. Evaluation of discomfort and pain by Visual Analog Scale (VAS) method up to 4 weeks after treatment. Evaluation of X-ray after 6 and 12 months after treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Following SRP, Er:YAG laser irradiation is performed with water spray at 30 Hz and 50-80 mJ at panel setting.
Interventions/Control_2
SRP
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The patient who is receiving periodontal therapy in Dental Hospital of Tokyo Medical and Dental University
2. Single rooted tooth with attachment loss, pocket depth of 5 mm or more, BOP (+), tooth mobility class I or less and bone defect depth of 3 mm or more
3. Based on the split mouth design, there are 1 or more teeth that meet the above conditions in 2 quadrants of the mouth.
Key exclusion criteria
1. Having systemic disease that can affect periodontal condition, such as diabetes
2. Smokers
3. In case of pregnancy or lactation
4. The history of anesthesia allergy
5. Receiving antimicrobial agent in the last 3 months
6. Having an infectious disease, such as hepatitis or HIV
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Aoki |
Organization
Tokyo Medical and Dental University
Division name
Department of Periodontology, Graduate School of Medical and Dental Sciences
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5488
aoperi@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Aoki |
Organization
Tokyo Medical and Dental University
Division name
Department of Periodontology, Graduate School of Medical and Dental Sciences
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5488
Homepage URL
aoperi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
Yushima1-5-45, Bunkyo-ku, Tokyo
Tel
03-5803-4523
d-hyoka.adm@tmd.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
東京医科歯科大学歯学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 16 | 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
| 2015 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 13 | 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
| 2018 | Year | 03 | Month | 08 | Day |
Last modified on
| 2021 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035827
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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