Efficacy Evaluation of iRoot SP and nRoot SP in Chronic Apical Periodontitis
This study aims to evaluate the therapeutic effect of iRoot SP and nRoot SP in treating chronic apical periodontitis, focusing on the reduction of periapical radiolucency and improvement in symptoms such as gingival swelling/pain, tooth discoloration, and occlusal discomfort.
iRoot SP
+ nRoot SP
Treatment Study
Summary
Study start date: May 27, 2025
Actual date on which the first participant was enrolled.This clinical trial focuses on patients with chronic apical periodontitis, a condition that affects the tip of the tooth root and surrounding tissues. The study compares the effectiveness of two domestically produced sealer pastes, iRoot SP and nRoot SP, used in root canal treatments. The main goal is to evaluate how well these materials work over a period of 3 to 24 months, looking at factors like reduction in swelling and pain, and improvement in chewing function. This study is important as it aims to provide reliable evidence for the optimal use and selection of these materials in clinical practice, ultimately improving treatment outcomes for patients with chronic apical periodontitis. During the trial, participants receive a root canal treatment using either iRoot SP or nRoot SP sealer paste. The effectiveness of the treatment is measured through post-treatment X-ray examinations, which look for changes in the size of the affected area at the tooth root tip. Additionally, the study evaluates improvements in symptoms such as gingival swelling/pain, tooth discoloration, and occlusal discomfort, as well as restoration of chewing function. The potential benefits for participants include improved dental health and reduced symptoms, while the risks are those typically associated with root canal treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.160 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou, ChinaOpen School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine in Google Maps