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

1-year Evaluation of iRoot SP as a Root Canal Sealer Compare to AH Plus Sealer: A Prospective Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Apical Periodontitis; Irreversible Pulpitis
• Intervention / Treatment: Procedure: Root canal sealer

• Study Type: Interventional
• Enrollment (Actual): 283
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessments	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.	1 year after root canal therapy
Postoperative Pain Evaluation	Pain was evaluated by using a visual analogue scale (VAS) made of a 10 cm line, where 0 = no pain and 10 = unbearable pain.	1 week after root canal therapy

Collaborators and Investigators

• Sponsor: Hui Chen
• Investigators: Study Chair: Hui Chen, Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 27, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Estimate): December 5, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Dental Pulp Diseases; Periapical Diseases; Periodontitis; Pulpitis; Periapical Periodontitis
• Other Study ID Numbers: DHZhejiangU