UMIN-CTR Clinical Trial

Basic information
Public title	Application of Er: YAG laser in Peri-implantitis treatment
Acronym	Application of Er: YAG laser in Peri-implantitis treatment
Scientific Title	Application of Er: YAG laser in Peri-implantitis treatment
Scientific Title:Acronym	Application of Er: YAG laser in Peri-implantitis treatment
Region	Japan

Condition
Condition	Peri-implantitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of the effects and safety of Er: YAG laser application in peri-implantitis treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of attachment level 1, 3, 6, 12 month after treatment.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	In surgical and non-surgical treatment for peri-implantitis, the implant body and the granulation tissues are debrided using an Er: YAG laser. In non-surgical treatment, after using local anesthesia, apply Er: YAG laser to debride granulation tissue in implant sulcus and debride the surface of the implant. In the surgical treatment, after using local anesthesia, flap is elevated, and granulation tissue of the bone defect is removed and the surface of the implant body is debrided with Er: YAG laser. Bone graft material (Bio-Oss: Geistlich Sons Ltd, Switzerland) and bone cement (cytranrance , GC, Japan) will be used for filling the bone defect with an absorbable membrane (BioGide, Geistlich Sons Ltd, Switzerland) in combination. Immediately after surgery, antibiotics and anti-inflammatory drugs are administered.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with Peri-Implant mucositis and Peri-implantitis Patient with good oral hygiene Patient without serious systemic diseases Non smoker or past smoker Patient with good compliance
Key exclusion criteria	Patient with serious systemic diseases Smoker
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akira Aoki
Organization	Tokyo Medical and Dental University
Division name	Periodontology department
Zip code
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5488
Email	akira-aoki.peri@tmd.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akira Aoki
Organization	Tokyo Medical and Dental University
Division name	Periodontology department
Zip code
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5488
Homepage URL
Email	akira-aoki.peri@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental 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
Address
Tel
Email

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	2018 Year 04 Month 01 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	Terminated
Date of protocol fixation	2014 Year 03 Month 19 Day
Date of IRB	2016 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 03 Month 19 Day
Last follow-up date	2019 Year 04 Month 12 Day
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 14 Day
Last modified on	2020 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036217