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

Hui Chen283 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

283

Conditions

Irreversible Pulpitis Apical Periodontitis

Interventions

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

Sex: ALLMin age: 12 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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".

Time frame: 1 year after root canal therapy

Secondary Outcomes

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.

Time frame: 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.

Time frame: 1 week after root canal therapy