臨床研究等提出・公開システム

Scientific Title	Study of safety and efficacy of antimicrobial photodynamic therapy for peri-implantitis
Public Title	Usefulness of antimicrobial photodynamic therapy for peri-implantitis

Completion date	April. 30, 2020
Result actual enrolment	26
Baseline Characteristics	21 patients (6 males and 15 females) with 25 implants were enrolled in this study. The irrigation and a-PDT groups included 13 (13 patients) and 12 implants (8 patients, two implants were subjected in 4 patients), respectively.
Participant flow	One case was dropped out.
Adverse events	None.
Outcome measures	a-PDT was safety treatment procedure for peri-implantitis. The pus discharge was decreased after a-PDT compared with irrigation for peri-implantitis with significant difference.
Brief summary	This study revealed that the safety of a-PDT with TB for the treatment of peri-implantitis, and a-PDT was confirmed to be successful for reducing inflammation and infection in peri-implant pockets. However, its effects were limited to when a-PDT was applied alone.
Date of posting of results summaries	Feb. 01, 2021
Date of the first journal publication of results	Sept. 01, 2020
URL hyperlink(s) related to results and publications	https://www.sciencedirect.com/science/article/pii/S1572100020302908?via%3Dihub

Plan to share IPD	No
Plan description	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs072190037

Contact for Scientific Queries	Name	Ohba Seigo
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto, Nagasaki-shi
	Telephone	+81-95-819-7704
	E-mail	sohba@nagasaki-u.ac.jp
Contact for Public Queries	Name	Ohba Seigo
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto, Nagasaki-shi
	Telephone	+81-95-819-7704
	E-mail	sohba@nagasaki-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 21, 2019
Actual date of first enrollment		Dec. 05, 2019
Target sample size		26
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with peri-implantitis
	Exclusion Criteria	Patients with problem in judgement
	Age Minimum	20age old over
	Age Maximum	89age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Peri-implantitis
Intervention(s)		Irrigation group: A periodontal pocket is irrigated with saline solution. Irrigation + a-PTD group: A periodontal pocket is irrigated with saline solution, and given photodynamic therapy with FotoSan630 using FotoSanAgent as photosensitizer.
Health Condition(s) Keyword		Peri-implantitis
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Pus discharge
Secondary Outcome(s)		Change in inflammation symptoms

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	The Clinical Research Review Board in Nagasaki University
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki
Telephone	+81-95-819-7905
E-Mail	gaibushikin@ml.nagasaki-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 11, 2019

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history