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

NCT03029520 | Completed DMC

• 1 other identifier: BAPKOM 4949
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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..

Conditions

Endodontically-Treated Teeth

Keywords

Endodontic Postoperative Pain; iRoot SP Sealer; Randomized Clinical Trial; Herofill carrier-based obturation

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative pain by using VAS scale after obturation with different sealers.

  72 hour

Study Arms (4)

pain iRoot SP sealer Vital Pulp

ACTIVE COMPARATOR

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.

Other: Root canal obturation with iRoot SP sealer

pain iRoot SP sealer Devital pulp

ACTIVE COMPARATOR

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.

Other: Root canal obturation with iRoot SP sealer

pain AHPlus Vital pulp

ACTIVE COMPARATOR

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.

Other: Root canal obturation with AH Plus Sealer

pain AHPlus Devital Pulp

ACTIVE COMPARATOR

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.

Other: Root canal obturation with AH Plus Sealer

Interventions

Root canal obturation with iRoot SP sealer OTHER

Postoperative pain after root canal obturation with iRoot SP sealer with patients who has (mandibular premolar/molar) vital and devital pulps.

pain iRoot SP sealer Devital pulp; pain iRoot SP sealer Vital Pulp

Root canal obturation with AH Plus Sealer OTHER

Postoperative pain after root canal obturation with AH Plus sealer with patients who has (mandibular premolar/molar) vital and devital pulps.

pain AHPlus Devital Pulp; pain AHPlus Vital pulp

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

Root Canal Obturation

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Root Canal Therapy; Endodontics; Dentistry

Study Officials

• oguz yoldas, professor

  vice dean

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 24, 2017
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 25, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share