Clinical and microbiological effects of a single application of a sodium hypochlorite gel in maintenance patients treated for periodontitis stages III-IV. A triple-blind randomized placebo-controlled clinical trial

Regedent (Switzerland)0 个研究点目标入组 85 人开始时间: 2021年12月9日最近更新: 2022年8月5日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35829773/ (added 14/07/2022)

•1. Men and women aged 20-80 years
•2. Treated periodontitis patients, that underwent supportive periodontal treatment for a minimum period of 6 months
•3. At least 4 non-adjacent sites with PPDs =4 mm with BOP or PPDs >5 mm, but not deeper than 8 mm, with or without BOP, according to the criteria for the need of retreatment in SPT (rate of healing) (Tonetti, Lang & Cortellini 2012); the sites should not be associated with affected furcations, in third molars and in teeth severely malpositioned teeth. Ideally, the teeth should be in different quadrants
•4. The teeth considered for assessment should be vital or should have an adequate root canal treatment
•5. Compliant patients (mean BOP <25%, PCR <25%)
•6. Patients who underwent systematic periodontal treatment in the same private practice where the study is conducted and have been documented regarding the periodontal evaluations, radiographs
•7. Patients willing to provide written informed consent
•8. Patients able to comply with 12-month study follow-up

•1. Known allergy or adverse reactions to hypochlorite
•2. Clinically relevant psychological disorders
•3. Alcohol abuse
•4. Known HIV infection
•5. Self-reported diabetes mellitus
•6. Locally or systemic administration of antibiotics in the last 3 months
•7. Pregnancy, breastfeeding
•If progression of periodontal destruction was observed or if adverse reactions to the test product were reported, the subject was removed from the study. Progression of periodontal destruction was defined as attachment loss > 2mm or an increase of PPD >2 mm between subsequent evaluations.

发起方

Regedent (Switzerland)