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

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981693
• Other study ID #: DHZhejiangU
• Status: Completed
• Phase: N/A
• First received: November 27, 2016
• Last updated: November 30, 2016
• Start date: January 2014
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: The Dental Hospital of Zhejiang University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apical Periodontitis
• Irreversible Pulpitis
• Periapical Periodontitis
• Periodontitis
• Pulpitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hui Chen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No