Post-Obturation Pain Following the Use of the AH Plus and iRoot SP Sealers

Not Applicable

Completed

• Conditions: Endodontically-Treated Teeth
• Interventions: Other: Root canal obturation with iRoot SP sealer; Other: Root canal obturation with AH Plus Sealer

• Registration Number: NCT03029520
• Lead Sponsor: Cukurova University

Brief Summary

The aim of this study was to evaluate and compare postoperative pain and overextension of root canal filling after root canal treatment using a carrier-based obturation system and two different sealers.

In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160 patients were treated. Patients with vital and devital teeth were assigned to four groups using a randomized block design with block sizes of 10 patients each. The groups were composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator prepared root canals and filled them with sealer using the carrier-based obturation technique. Radiographs were taken and obturation length was recorded. Patients recorded pain scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6, 6-12, 12-24, and 24-72 h..

Detailed Description

This randomized controlled clinical study was conducted to compare the incidence and intensity of post-obturation pain, evaluate the overextension of filling material radiographically, and assess the relationship between pain and analgesic intake in patients with vital and devital teeth undergoing carrier-based obturation with two different sealers (iRoot SP, AH Plus)

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-24
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• no systemic diseases
• women were not pregnant or breastfeeding status
• no history of taking analgesics in the previous seven days or other drugs prior to presenting for treatment.
• all selected teeth were mandibular molar or mandibular premolar.

Exclusion Criteria

• systemic and/or periodontal disease;
• allergy to local anesthetic agents and/or history of intolerance to nonsteroidal anti-inflammatory drugs;
• requirement for antibiotic prophylaxis
• open tooth apex
• pacemaker use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pain iRoot SP sealer Vital Pulp	Root canal obturation with iRoot SP sealer	Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) vital pulp.
pain AHPlus Devital Pulp	Root canal obturation with AH Plus Sealer	Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) devital pulp.
pain iRoot SP sealer Devital pulp	Root canal obturation with iRoot SP sealer	Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) devital pulp.
pain AHPlus Vital pulp	Root canal obturation with AH Plus Sealer	Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) vital pulp.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative pain by using VAS scale after obturation with different sealers.	72 hour