1-year Evaluation of iRoot SP as a Root Canal Sealer Compare to AH Plus Sealer: A Prospective Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 283
- Primary Endpoint
- Radiographical assessments
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
AH Plus sealer
AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation.
Intervention: Root canal sealer (Procedure)
iRoot SP sealer
iRoot SP sealer was used as root canal sealer in root canal obturation.
Intervention: Root canal sealer (Procedure)
Outcomes
Primary Outcomes
Radiographical assessments
Time Frame: 1 year after root canal therapy
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".
Secondary Outcomes
- Clinical assessments(1 year after root canal therapy)
- Postoperative Pain Evaluation(1 week after root canal therapy)
Investigators
Hui Chen
Professor
The Dental Hospital of Zhejiang University School of Medicine