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Aug. 08, 2022

Mar. 31, 2026

jRCTs041220050

Bactericidal Effect of Antimicrobial Photodynamic Periodontal Therapy for Lasers using 'biological Window' of Optical Propeties

Bactericidal Effect in Periodontal Treatment using Laser and Photosensitizer

Dec. 31, 2024

64

The subjects were patients who were currently visiting the Department of Periodontology at Aichi Gakuin University Hospital for treatment of periodontal disease, had completed active treatment, were in the SPT stage, had residual periodontal pockets of 5 mm or more, and had stable occlusion. Patients who can visit the hospital for two consecutive weeks. Patients who are not allergic to shellfish. Patients who have not taken immunosuppressants, corticosteroids, or antibiotics in the past three months.

Patients who were undergoing treatment at the Aichi Gakuin University Hospital Periodontics Department for periodontal disease, had completed active treatment, had a residual periodontal pocket of 5mm or more, and had a stable occlusion. They were also able to visit the hospital for two consecutive weeks. They were not allergic to shellfish. They had not taken immunosuppressants, corticosteroids, or antibiotics in the past three months. 65 patients were adults aged 20 years or older who were able to visit the hospital for two consecutive weeks and who gave their consent. Allocation was by lottery. Results The control group consisted of 31 patients (11 men; 36-81 average 57.5; 20 women; 53-80 average 69.4), and the experimental group consisted of 33 patients (13 men; 41-85 average 68.0; 20 women; 33-91 average 69.0). Consent was obtained from 70 subjects. Five subjects withdrew their consent, and one subject discontinued the study at Mirai Hospital for the second time. The control group had 31 subjects, but one subject had zero viable bacterial counts in the culture. In addition, one subject had Candida contamination in the culture medium one week after surgery. The experimental group consisted of 33 subjects, but because the study was conducted at Mirai Hospital one week after surgery, there were 32 subjects.

none

Primary outcome 1.Comparison of changes in bacterial counts before and immediately after surgery in the control and experimental groups. Control group: No significant difference was observed before and immediately after surgery. Experimental group: A significant difference was observed before and immediately after surgery. Secondary outcome 1. Comparison of bacterial counts before and one week after surgery in the control and experimental groups. Control group: No significant difference was observed before and one week after surgery. Experimental group: A significant difference was observed before and one week after surgery. 2. Changes in bacterial flora (red complex) before and one week after surgery. No significant difference was observed in the control group's red complex before and one week after surgery. No significant difference was observed in the experimental group's red complex before and one week after surgery. 3.Changes in bleeding on probing (BOP) before and one week after surgery. No significant difference was observed between the control and experimental groups. Clinical indices other than secondary endpoints 1. Comparison of the reduction rate of viable bacteria count before and after surgery between the control and experimental groups. A significant difference was observed between the control and experimental groups before and immediately after surgery. No significant difference was observed between the control and experimental groups before and one week after surgery. 2. Changes in pocket (probing depth: PD). A significant difference was observed before and after surgery in the experimental group. No significant difference was observed in the control group. 3. Pain during surgery. On the VAS scale, only one case was 10out of 100 or higher, and most were 0.

In the experimental group, it was confirmed that bacteria in the pocket were reduced, and changes in the bacterial flora continued until one week afterwards. It was confirmed that the laser light penetrated the gingival tissue and showed the PDT effect. No adverse events, including allergies, were observed, and safety was confirmed. Most patients (experimental group 25/32; control group 17/31) did not complain of pain during surgery. Rather than pain, they complained of dry mouth caused by air irradiati

Mar. 31, 2026

No

Not yet decided.

https://jrct.mhlw.go.jp/latest-detail/jRCTs041220050

Fukuda Mitsuo

Aichi Gakuin University Dental Hospital

2-11 Suemori-Dori, Chikusa-ku, Nagoya, Japan

+81-52-759-2150

fukuda-m@dpc.agu.ac.jp

Hayashi Jun-ichiro

Aichi Gakuin University Dental Hospital

2-11 Suemori-Dori, Chikusa-ku, Nagoya, Japan

+81-52-759-2150

jun1row@dpc.agu.ac.jp

Complete

Aug. 08, 2022

Aug. 17, 2022
70

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

prevention purpose

(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

(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

20age old over
No limit

Both

Periodontitis

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.

periodontitis

Reduction rate of live bacterial number before and immediately after procedure.

(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

Grant-in -Aid for Scientific Reaserch, Public Interest Incorporated Foundation 'The Hori Science and Arts Foundation'
Not applicable
Nagoya City University Certified Review Board
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi , Aichi

+81-52-853-8346

rinshou-kenkyu@med.nagoya-cu.ac.jp
Approval

Aug. 02, 2022

none

History of Changes

No Publication date
6 Mar. 31, 2026 (this page) Changes
5 May. 24, 2024 Detail Changes
4 Oct. 16, 2023 Detail Changes
3 Sept. 19, 2023 Detail Changes
2 Feb. 08, 2023 Detail Changes
1 Aug. 08, 2022 Detail