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

Hui Chen

Status: Completed

Conditions: Apical Periodontitis; Irreversible Pulpitis

Treatments: Procedure: Root canal sealer

Study type: Interventional

Funder types: Other

Identifiers

NCT02981693

DHZhejiangU

Details and patient eligibility

About

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.

Enrollment: 283 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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283 participants in 2 patient groups

iRoot SP sealer

Experimental group

Description:

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

Treatment:

Procedure: Root canal sealer

AH Plus sealer

Active Comparator group

Description:

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

Treatment:

Procedure: Root canal sealer