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
Disclaimer: Curated by HT Syndication.