Tokyo, March 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060527) titled 'The effect of preoperative mouthwash usage on the periodontal regeneration therapy' on March 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Nihon University

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

Objective: Narrative objectives1 - Periodontal tissue regeneration therapy is widely practiced under insurance coverage, such as REGROTH. Patients undergoing surgery must receive periodontal initial therapy to reduce inflammation at preoperative periodontal reevaluation. However, preoperative administration of antibiotics is not permitted unless there is a clear impact on systemic health. This study evaluates the efficacy of preoperative use of a highly active CPC mouthwash, using postoperative pain and the degree of improvement in clinical parameters following periodontal tissue regeneration therapy as outcomes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - CPC mouthwash use Interventions/Control_2 - Placebo mouthwash use

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - The study population consists of 80 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 11 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=R000069234

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