臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 08, 2022
Last modified on	May. 24, 2024
Trial ID	jRCTs041220050

Scientific Title	Bactericidal Effect of Antimicrobial Photodynamic Periodontal Therapy for Lasers using 'biological Window' of Optical Propeties
Public Title	Bactericidal Effect in Periodontal Treatment using Laser and Photosensitizer

Contact for Scientific Queries	Name	Fukuda Mitsuo
	Affiliation	Aichi Gakuin University Dental Hospital
	Address	2-11 Suemori-Dori, Chikusa-ku, Nagoya, Japan
	Telephone	+81-52-759-2150
	E-mail	fukuda-m@dpc.agu.ac.jp
Contact for Public Queries	Name	Hayashi Jun-ichiro
	Affiliation	Aichi Gakuin University Dental Hospital
	Address	2-11 Suemori-Dori, Chikusa-ku, Nagoya, Japan
	Telephone	+81-52-759-2150
	E-mail	jun1row@dpc.agu.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Aug. 08, 2022
Actual date of first enrollment
Target sample size		70
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Healthy adult with periodontal disease as follows Those who have teeth with residual periodontal pocket of 5 mm or more If there are some teeth with a residual periodontal pocket of 5 mm or more, select based on the following criteria 1) Deeper pocket teeth 2) Upper jaw teeth 3) More mesial teeth 4) Right tooth Those who have a stable occlusion (2) Patients aged 20 years or older (3) Patients who can visit the hospital for 2 consecutive weeks (4) Patients who have given written consent to participate in this study
	Exclusion Criteria	(1) Patients taking antibiotics within the last 3 months (2) Patients who have taken or are taking anti-cancer drugs within 6 months (3) Patients with a history of allergies to Indocyanin Green (4) Patients with a history of allergies to shellfish (5) Pregnant, lactating and potentially pregnant or willing women (6) Patients taking immunosuppressive agents and corticosteroids within the last 3 months (7) Other patients who are judged by the research responsible / shared doctor to be inappropriate as research subjects
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Periodontitis
Intervention(s)		Experimental group:injecect 0.2mL Nano particle(10mg/mL) solution into periodontal pockets with syringe connected of 27G blunt needle. Contorol group:injecect 0.2mL distiled saline solution into periodontal pockets with syringe connected of 27G blunt needle.
Health Condition(s) Keyword		periodontitis
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Reduction rate of live bacterial number before and immediately after procedure.
Secondary Outcome(s)		(1) Change rate of red complex before and one week after procedure using real time PCR (2) Change of bleeding on probing before and one week after procedure (3) Comparison of live bacterial cell counts before and 1 week after procedure

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Grant-in -Aid for Scientific Reaserch, Public Interest Incorporated Foundation 'The Hori Science and Arts Foundation'
Secondary Sponsor	Not applicable

Name of Certified Review Board	Nagoya City University Certified Review Board
Address	1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi , Aichi
Telephone	+81-52-853-8346
E-Mail	rinshou-kenkyu@med.nagoya-cu.ac.jp
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	May. 24, 2024	(this page)	Changes
4	Oct. 16, 2023	Detail	Changes
3	Sept. 19, 2023	Detail	Changes
2	Feb. 08, 2023	Detail	Changes
1	Aug. 08, 2022	Detail

List of change history