Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060529) titled 'Efficacy Tests for Toothpaste and Mouthwash' on Feb. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Aichi Gakuin University
Condition:
Condition - Periodontal disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluate the efficacy of formulations containing CPC and beta-glycyrrhetinic acid in improving periodontal disease compared to formulations containing CHX.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Use of CPC + beta-glycyrrhetinic acid paste and liquid formulations at least twice daily for 3 months.
Interventions/Control_2 - Use of chlorhexidine-containing paste and CHX + MAG liquid formulation at least twice daily for 3 months.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Patients who have received explanations about the purpose, content, and side effects of this study, fully understood them, voluntarily wished to participate in the study,
and provided written informed consent
(2) Patients who have 16 or more remaining teeth
(3) Patients who have stable teeth with a PPD of 4-8mm, excluding third molars
(4) Patients who are 20 years of age or older at the time of obtaining consent
Key exclusion criteria - (1) Patients who have been administered antibiotics (antimicrobial agents) within 1 month before the start of the study
(2) Patients currently being treated for cancer, stroke, acute myocardial infarction, diabetes, or autoimmune diseases
(3) Pregnant or breastfeeding individuals
(4) Smokers
(5) Patients who have experienced allergic reactions to toothpaste in the past
(6) Patients who are visiting a dental clinic and receiving treatment for oral diseases other than periodontal disease
(7) Patients currently participating in other clinical trials related to oral health
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 05 Day
Date of IRB - 2025 Year 09 Month 29 Day
Anticipated trial start date - 2026 Year 02 Month 06 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069219
Disclaimer: Curated by HT Syndication.