Tokyo, July 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058646) titled 'Research on periodontal treatment using hydrogen peroxide photolysis' on July 30.
Study Type:
Interventional
Study Design:
Basic Design - Factorial
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Nihon University School of Dentistry at Matsudo
Condition:
Condition - Periodontitis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We will examine the effectiveness of periodontal treatment combined with hydrogen peroxide photolysis technology in improving clinical parameters of periodontal disease and consider the usefulness of Blue Radical P-01.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Blue Radical P-01 is used in combination with subgingival SRP using a hand scaler under local anesthesia.
Interventions/Control_2 - Ultrasonic scaler is used in combination with subgingival SRP using a hand scaler under local anesthesia.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Stage III/IV periodontitis patients have at least 3 teeth with 6 mm PD or more
Key exclusion criteria - 1. smokers
2. having received antibiotic therapy and/or subgingival periodontal therapy in the previous 12 weeks
3. uncontrolled diabetes
4. presence of acute symptoms
5. taking medication affecting the periodontal condition (ex, phenytoin, nifedipine, or cyclosporine A)
6. pregnancy or breastfeeding
7. patients with pacemakers
8. patients with acatalasemia
Target Size - 94
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 01 Month 20 Day
Date of IRB - 2025 Year 02 Month 28 Day
Anticipated trial start date - 2025 Year 03 Month 01 Day
Last follow-up date - 2030 Year 02 Month 27 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065563
Disclaimer: Curated by HT Syndication.