Chronic Apical PeriodontitisNCT07388901
In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal Sealers
A study testing iRoot SP and nRoot SP in people with Chronic Apical Periodontitis, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
A randomized controlled trial was conducted to compare the treatment efficacy of iRoot SP and nRoot SP Root Canal Sealer Materials in patients with chronic apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Apical Periodontitis
- What is being tested?
- iRoot SP and nRoot SP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2025to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Diagnosis of apical periodontitis conforming to the diagnostic criteria in Endodontics.
- The affected tooth is deemed restorable upon evaluation, with non-vital pulp requiring extirpation.
- The affected tooth is a single tooth with a fully developed apical foramen.
- No root resorption and no significant morphological variation of the root canal.
- The affected tooth is undergoing primary root canal treatment.
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- 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.
- Patient has provided informed consent.
Who cannot join
- Patients with alveolar bone loss exceeding one-third of the root length.
- Affected teeth with root fracture, root canal obstruction, calcification, or root surface caries.
- Patients with severe systemic diseases (e.g., osteoporosis, mental disorders, hepatic or renal insufficiency).
- Patients who have taken analgesics, immunosuppressants, or antibiotics within one week prior to enrollment.
- Patients with concurrent periapical cysts, oral tumors, or other oral diseases.
- Pregnant or lactating patients.
- Patients with dental phobia, severe gag reflex, limited mouth opening, or poor compliance.
- Patients with a known allergy to the root canal sealer materials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Tu Yan, +8615858224066, tuyan1984@zju.edu.cn
About this study
Official title: Randomized Controlled Trial of iRoot SP (Injectable Root Canal Sealer Paste) and nRoot SP (ENPUNUO Root Canal Sealer Paste) in Patients With Chronic Apical Periodontitis
A randomized controlled trial was conducted to compare the treatment efficacy of iRoot SP and nRoot SP Root Canal Sealer Materials in patients with chronic apical periodontitis.
Read the detailed description
This study aims to conduct a randomized controlled clinical trial to evaluate the 3-24months efficacy (including radiographic reduction of periapical radiolucency, postoperative pain, etc.) of the two materials in patients with chronic apical periodontitis. The objective is to provide evidence-based support for the optimization and clinical selection of domestically produced materials, thereby promoting the precise application of bioceramic sealers.
- Conditions
- Chronic Apical Periodontitis
- Being tested
- iRoot SP, nRoot SP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iRoot SPDevice
use iRoot SP in root canal treatment
nRoot SPDevice
use nRoot SP in root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| iRoot SP | Active comparator | iRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment. Receives: Device: iRoot SP |
| nRoot SP | Experimental | nRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment. Receives: Device: nRoot SP |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic effect
Markedly Effective: Post-treatment X-ray examination shows complete resolution of the periapical radiolucency. The patient's chewing function is largely restored, and symptoms such as gingival swelling/pain, tooth discoloration, and occlusal discomfort have disappeared.
Effective: Post-treatment X-ray examination shows significant reduction in the size of the radiolucency. The patient may experience mild percussion pain or discomfort. Chewing function is largely normal, and symptoms such as gingival swelling/pain, tooth discoloration, and occlusal discomfort show improvement.
Ineffective: Post-treatment X-ray examination shows no reduction or even enlargement of the radiolucency. The patient reports significant percussion pain. Symptoms such as gingival swelling/pain, tooth discoloration, and occlusal discomfort show no improvement.
Measured: 3,6,12,24months
Secondary outcomes (2)
clinical manifestation
Four distinct clinical assessments to be evaluated at 3, 6, 12, and 24 months postoperatively: tooth mobility, assessed clinically using a standard grading scale (Miller index. Grade I: Mobility with a buccolingual displacement of ≤1 mm; Grade II: Mobility with a buccolingual displacement of 1-2 mm, possibly accompanied by slight mesiodistal mobility; Grade III: Mobility with a buccolingual or mesiodistal displacement exceeding 2 mm, or the presence of vertical mobility.) ; periodontal probing depth, measured at designated sites(mesiobuccal, midbuccal, distobuccal mesiolingual, midlingual, distolingual).) around the tooth with a periodontal probe and recorded in millimeters; percussion pain, evaluated by vertical and horizontal tapping and documented either as a binary presence/absence; the presence of a sinus tract, determined through visual inspection and verification with a gutta-percha point if necessary and recorded as a binary outcome. Each parameter will be analyzed independent
Measured: 3,6,12,24months
Imaging findings
Change in the size of the periapical radiolucent area. Specifically, after acquiring the image, the DICOM format image will be imported into 3D slicer, the maximum diameter of the apical low-density shadow will be measured using the ruler function, the range of the apical low-density shadow will be divided using the segment editor module, and the volume of the periapical shadow will be calculated using the segment statistics module
Measured: 3,6,12,24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start27 May 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tu Yan, Principal investigator, School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388901
- Sponsor's protocol ID
- 2025-064
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No