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Efficacy Evaluation of iRoot SP and nRoot SP in Chronic Apical Periodontitis

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Study Aim

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.

What is being tested

iRoot SP

+ nRoot SP

Device
Who is being recruted

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorThe Dental Hospital of Zhejiang University School of Medicine
Study ContactTu Yan
Last updated: February 6, 2026
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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.

Official TitleRandomized Controlled Trial of iRoot SP (Injectable Root Canal Sealer Paste) and nRoot SP (ENPUNUO Root Canal Sealer Paste) in Patients With Chronic Apical Periodontitis
Principal SponsorThe Dental Hospital of Zhejiang University School of Medicine
Study ContactTu Yan
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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

9 inclusion criteria required to participate
The affected tooth is a single tooth with a fully developed apical foramen.

Diagnosis of apical periodontitis conforming to the diagnostic criteria in Endodontics.

Periapical radiolucency with a diameter of 1-5 mm and no peripheral sclerotic border observed on preoperative radiographs.

Patient is in normal mental state, conscious, and capable of normal communication.

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8 exclusion criteria prevent from participating
Patients with dental phobia, severe gag reflex, limited mouth opening, or poor compliance.

Affected teeth with root fracture, root canal obstruction, calcification, or root surface caries.

Patients who have taken analgesics, immunosuppressants, or antibiotics within one week prior to enrollment.

Patients with alveolar bone loss exceeding one-third of the root length.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
iRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment.

Group II

Experimental
nRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment.

Study 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

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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
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One Study Center