Tokyo, March 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060532) titled 'The effect of postoperative mouthwash on periodontal regeneration therapy' on March 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Nihon University

Condition: Condition - chronic periodontitis, moderate to severe Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - For several weeks following periodontal tissue regeneration therapy, mechanical oral hygiene management at the surgical site is not allowed. Therefore, the use of mouthwash is essential. Benzethonium chloride mouthwash, a pharmaceutical product, is widely used. However, the difference in efficacy compared to anti-inflammatory mouthwash containing tranexamic acid remains unclear. Therefore, we will evaluate the effectiveness of these products by administering postoperative management using both benzethonium chloride mouthwash and tranexamic acid-containing mouthwash during postoperative rinsing. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Use of tranexamic acid mouthwash Interventions/Control_2 - Use of benzethonium chloride Mouthwash

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - The study population consists of patients aged 20 years or older with Stage III-IV periodontitis who visited the Periodontology Department at Nihon University Matsudo Dental Hospital. Selection criteria for subjects were based on re-evaluation findings after subgingival SRP under local anesthesia and radiographic evaluation of vertical intrabony defects with bone loss depth more than 3mm and pocket depth (PD) more than 5mm. Subjects had to consent to undergoing periodontal tissue regeneration therapy (REGROTH). Key exclusion criteria - 1.Smokers 2.Patients with uncontrolled diabetes 3.Those with acute symptoms 4.Those taking medications that may affect periodontal tissues (e.g., phenytoin, nifedipine, cyclosporine A) 5.Pregnant or breastfeeding individuals 6.Those with a history of oral cancer 7.Those with alcohol hypersensitivity. Target Size - 66

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 30 Day Anticipated trial start date - 2026 Year 03 Month 13 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069243

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