UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008790 |
|---|---|
| Receipt number | R000010330 |
| Scientific Title | Healing effects of Er: YAG laser on peri-implant mucositis and peri-implantitis: a clinical randomized controlled trial. |
| Date of disclosure of the study information | 2012/09/24 |
| Last modified on | 2018/11/27 18:14:19 |
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Basic information
Public title
Healing effects of Er: YAG laser on peri-implant mucositis and peri-implantitis: a clinical randomized controlled trial.
Acronym
Healing effects of Er: YAG laser on peri-implant mucositis and peri-implantitis.
Scientific Title
Healing effects of Er: YAG laser on peri-implant mucositis and peri-implantitis: a clinical randomized controlled trial.
Scientific Title:Acronym
Healing effects of Er: YAG laser on peri-implant mucositis and peri-implantitis.
Region
| Japan |
Condition
Condition
Peri-implant mucositis and peri-implantitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical and microbiological effects and changes of cytokine expression levels by Er: YAG laser treatment for peri- implant mucositis and peri-implantitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cytokine expression levels in peri-implant crevicular fluid
Key secondary outcomes
Species and numbers of subgingival bacteria
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
| Medicine |
Interventions/Control_1
Test group
1: 18patients
2: Er: YAG laser beam is delivered into the pocket of implant using PS600T tip at 30mJ/25pps under water irrigation.
Interventions/Control_2
Control group
1: 18 patients
2: 2% minocycline ointment is delivered into the pocket of 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Moderate to severe peri-implant mucositis and peri-implantitis.
2.Having probing pocket depth(PPD) equal or greater than 5mm and bleeding on probing(BOP) positive.
Key exclusion criteria
1.Persons who have acute inflammation of the tooth next to the candidate implant.
2.Persons who take systemic antibiotics or anti-inflammatory drugs within 3 months before experiment.
3.Persons who have severe systemic diseases.
4.Pregnancy in women.
5.Persons who have heart pacemaker or any other systemic conditions that might be affected byEr: YAG laser treatment.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Yoshie |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Periodontology
Zip code
Address
2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL
025-227-2871
yoshie@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasutaka Komatsu |
Organization
Niigata University Medical & Dental Hospital
Division name
Department of Periodontics
Zip code
Address
1-754 Asahimachi-Dori, Chuo-ku, Niigata, 951-8520, Japan
TEL
025-227-2871
Homepage URL
komatsu@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
J. Morita Mfg. Corp, Kyoto, Japan.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1.Department of Periodontology, Faculty of Dentistry, Asahi University
2.Department of Periodontology, Osaka Dental University
3.Yamamoto Dental Office
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
新潟大学医歯学総合病院（新潟県）
朝日大学歯学部付属病院（岐阜県）
大阪歯科大学附属病院（大阪府）
山本歯科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | 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
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
| 2012 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 24 | 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 | 08 | Month | 28 | Day |
Last modified on
| 2018 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010330
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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