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

NCT02981693 | Completed

• 1 other identifier: DHZhejiangU
• Study Type: interventional
• Target: 283
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Radiographical assessments

  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".

  1 year after root canal therapy

Secondary Outcomes (2)

• Clinical assessments

  1 year after root canal therapy

• Postoperative Pain Evaluation

  1 week after root canal therapy

Study Arms (2)

iRoot SP sealer

EXPERIMENTAL

iRoot SP sealer was used as root canal sealer in root canal obturation.

Procedure: Root canal sealer

AH Plus sealer

ACTIVE COMPARATOR

AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation.

Procedure: Root canal sealer

Interventions

Root canal sealer PROCEDURE

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.

AH Plus sealer; iRoot SP sealer

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects were required to:
• have a mature tooth with closed apices;
• have one single or multi-rooted tooth with irreversible pulpitis, pulp necrosis or apical periodontitis;
• be prepared to appear for follow-up and
• sign informed consent form.

You may not qualify if:

• Subjects with:
• moderate or severe marginal periodontitis;
• internal or external root resorption in periapical radiograph;
• active systemic disease;
• physical or mental disability,
• pregnant or lactating

Sponsors & Collaborators

• Hui Chen: lead

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Hui Chen

  Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: December 5, 2016
• Study Start: January 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2016-11