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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981693
First Posted: December 5, 2016
Last Update Posted: December 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hui Chen, The Dental Hospital of Zhejiang University School of Medicine
  Purpose
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.

Condition Intervention
Irreversible Pulpitis Apical Periodontitis Procedure: Root canal sealer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 1-year Evaluation of iRoot SP as a Root Canal Sealer Compare to AH Plus Sealer: A Prospective Clinical Study

Further study details as provided by Hui Chen, The Dental Hospital of Zhejiang University School of Medicine:

Primary Outcome Measures:
  • Radiographical assessments [ Time Frame: 1 year after root canal therapy ]
    The periapical status was assessed in the radiographs.Teeth with complete restitution of the periodontal contours were judged as "healed". Teeth with a clearly decreased size of the periapical radiolucency were judged as "healing". Teeth with unchanged, increased, or new periapical radiolucency were judged as "failed".


Secondary Outcome Measures:
  • Clinical assessments [ Time Frame: 1 year after root canal therapy ]
    The root filled tooth was considered clinically successful if there was absence of clinical sign or symptom such as spontaneous pain, sensitivity to percussion or palpation, abnormal mobility, signs of pathology like abscess or sinus tract.

  • Postoperative Pain Evaluation [ Time Frame: 1 week after root canal therapy ]
    Pain was evaluated by using a visual analogue scale (VAS) made of a 10 cm line, where 0 = no pain and 10 = unbearable pain.


Enrollment: 283
Study Start Date: January 2014
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iRoot SP sealer
iRoot SP sealer was used as root canal sealer in root canal obturation.
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.
Active Comparator: AH Plus sealer
AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects were required to:

  1. have a mature tooth with closed apices;
  2. have one single or multi-rooted tooth with irreversible pulpitis, pulp necrosis or apical periodontitis;
  3. be prepared to appear for follow-up and
  4. sign informed consent form.

Exclusion Criteria:

Subjects with:

  1. moderate or severe marginal periodontitis;
  2. internal or external root resorption in periapical radiograph;
  3. active systemic disease;
  4. physical or mental disability,
  5. pregnant or lactating
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981693


Sponsors and Collaborators
Hui Chen
Investigators
Study Chair: Hui Chen Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University
  More Information

Responsible Party: Hui Chen, Professor, The Dental Hospital of Zhejiang University School of Medicine
ClinicalTrials.gov Identifier: NCT02981693     History of Changes
Other Study ID Numbers: DHZhejiangU
First Submitted: November 27, 2016
First Posted: December 5, 2016
Last Update Posted: December 5, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Periodontitis
Pulpitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Pulp Diseases
Tooth Diseases
Periapical Diseases
Jaw Diseases