Bactericidal Effect in Periodontal Treatment using Laser and Photosensitizer

JRCT ID: jRCTs041220050

Registered date:08/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Periodontitis
• Date of first enrollment: 17/08/2022
• Target sample size: 70
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Reduction rate of live bacterial number before and immediately after procedure.

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Fukuda Mitsuo
• Source(s) of Monetary Support: Grant-in -Aid for Scientific Reaserch, Public Interest Incorporated Foundation 'The Hori Science and Arts Foundation'