UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048150 |
|---|---|
| Receipt number | R000044546 |
| Scientific Title | Treatment of peri-implantitis using Er: YAG laser under oral antibacterial medication |
| Date of disclosure of the study information | 2022/06/24 |
| Last modified on | 2024/12/27 09:44:33 |
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Basic information
Public title
Treatment of peri-implantitis using Er: YAG laser under oral antibacterial medication
Acronym
Treatment of peri-implantitis using Er: YAG laser
Scientific Title
Treatment of peri-implantitis using Er: YAG laser under oral antibacterial medication
Scientific Title:Acronym
Treatment of peri-implantitis using Er: YAG laser
Region
| Japan |
Condition
Condition
Peri-implantitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Purpose of this study is to develop laser therapy combined with a new useful antimicrobial agent for Peri-implantitis and verify the efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amounts of bacteria
Evaluation time: At the start of the study, after pocket irrigation, after LDDS, after taking Er: YAG with oral antibiotics, after follow-up or after surgery.
Key secondary outcomes
periodontal pocket depth, GI, BOP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
pocket irrigation 1 time
LDDS 2 time/day,2~4weeks
Er:YAG irradiation with oral antibiotics
1 time
surgery 1 time
Interventions/Control_2
No treatment:patients who have healty implant
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
Age 20 years old or older
The residual teeth more than 15 teeth
peri-implantitis of CIST class C or D
Key exclusion criteria
Person with aserious sysytemic disease
Person tho dentist judged in adequate
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Gomi |
Organization
Tsurumi University, School of Dental Medicine
Division name
Department of Periodontology
Zip code
230-8501
Address
2-1-3,Tsurumi, Tsurumi-ku, Yokohama
TEL
045-580-8431
gomi-k@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Shirakawa |
Organization
Tsurumi University,School of Dental Medicine
Division name
Department of Periodontology
Zip code
230-8501
Address
2-1-3 Tsurumi, Tsurumi-ku,Yokohama
TEL
045-580-8433
Homepage URL
shirakawa-satoshi@tsurumi-u.ac.jp
Sponsor or person
Institute
Department of Periodontology, School of Dental Medicine, Tsurui University.
Institute
Department
Personal name
Funding Source
Organization
Department of Periodontology, School of Dental Medicine, Tsurui University.
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
Tsurumi University Education Research Support Center Administrative Division Education Research Support Division
Address
2-1-3 Tsurumi, Tsurumi-ku, yokohama
Tel
045-580-8318
rinrishinsa@tsurumi-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 24 | 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
25
Results
The results of peri-implantitis tests were improved by Er:YAG laser irradiation while taking antibiotics.
Results date posted
| 2024 | Year | 12 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to the delay in data analysis.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No special notes
Outcome measures
Periodontal pocket depth, BOP, gingivitis index,
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044546
