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

NCT ID: NCT02981693

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Irreversible Pulpitis Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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iRoot SP sealer

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

Group Type EXPERIMENTAL

Root canal sealer

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Root canal sealer

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hui Chen

OTHER

Sponsor Role lead

Responsible Party

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Hui Chen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hui Chen

Role: STUDY_CHAIR

Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University

Other Identifiers

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DHZhejiangU

Identifier Type: -

Identifier Source: org_study_id