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

Study Overview
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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.

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

Conditions
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Irreversible Pulpitis, Apical Periodontitis

Intervention / Treatment
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* Procedure: Root canal sealer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iRoot SP sealer<br>iRoot SP sealer was used as root canal sealer in root canal obturation. | Procedure: Root canal sealer<br>* 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.<br>|
| Active Comparator: AH Plus sealer<br>AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation. | Procedure: Root canal sealer<br>* 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.<br>|

What is the study measuring?
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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 |