Periodontitis Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
China
School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Tu Yan
tuyan1984@zju.edu.cn
+8615858224066
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 160
Treatments
Active_comparator: iRoot SP
iRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment.
Experimental: nRoot SP
nRoot SP was used as the root canal sealer material during the root canal filling step of the root canal treatment.
Related Therapeutic Areas
Sponsors
Leads: The Dental Hospital of Zhejiang University School of Medicine

This content was sourced from clinicaltrials.gov