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Evaluation of iRoot SP as Root Canal Sealer: A Clinical Study

NCT02981693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2016-12-05

No results posted yet for this study

Summary

The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus arm randomly. After root canal shaping and cleaning, the teeth were obturated according to their arms. Assessment of postoperative pain was done 1 week after root canal obturation using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were carried out. Statistical analysis at P \< 0.05 was conducted to measure difference between the arms.

Conditions

  • Irreversible Pulpitis
  • Apical Periodontitis

Interventions

PROCEDURE

Root canal sealer

Patients who required root canal therapy were enrolled and allotted into either iRoot SP arm or AH Plus arm randomly.For Test Arm: iRoot SP was used as a sealer. Obturation was performed with Gutta-percha cones and root canal sealer by continuous-wave condensation technique. For Control Arm: AH Plus was used as root canal sealer. The same steps were followed for obturation as in Test Arm.

Sponsors & Collaborators

  • Hui Chen

    lead OTHER

Principal Investigators

  • Hui Chen · Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-11-30
Completion
2016-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02981693 on ClinicalTrials.gov