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 chronic periodontitis
Public Title	Usefulness of antimicrobial photodynamic therapy for chronic periodontitis

Completion date	May. 01, 2020
Result actual enrolment	60
Baseline Characteristics	Male: 13, Female: 17. Mean age: 58.4years. Irrigation: 30, a-PDT: 30
Participant flow	The number of registrations reached the planned number, and registration was completed during the originally scheduled period.
Adverse events	None.
Outcome measures	A significant difference was observed in the periodontal pocket compared with the control group. There was no significant difference in the degree of agitation. BOP was significantly decreased in the PDT group (P <0.05). No adverse events were observed on either day in all cases.
Brief summary	It was suggested that antibacterial photodynamic therapy using FotoSan is effective in reducing periodontal pockets and BOP remaining after basic periodontal therapy.
Date of posting of results summaries	June. 01, 2022
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

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/jRCTs072190034

Contact for Scientific Queries	Name	Yamashita Yasunori
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto, Nagasaki-shi
	Telephone	+81-95-819-7704
	E-mail	yamachanpon@nagasaki-u.ac.jp
Contact for Public Queries	Name	Yamashita Yasunori
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto, Nagasaki-shi
	Telephone	+81-95-819-7683
	E-mail	yamachanpon@nagasaki-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 15, 2019
Actual date of first enrollment		Feb. 04, 2020
Target sample size		60
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 periodontitis
	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		Periodontitis
Intervention(s)		Irrigation group: A periodontal pocket is irrigated with an ultrasonic scaler. Irrigation + a-PTD group: A periodontal pocket is irrigated with an ultrasonic scaler, and given photodynamic therapy with FotoSan630 using FotoSanAgent as photosensitizer.
Health Condition(s) Keyword		Periodontitis
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Bleeding on Probing
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