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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03029520
Other study ID # BAPKOM 4949
Secondary ID
Status Completed
Phase N/A
First received January 11, 2017
Last updated January 24, 2017
Start date July 2015
Est. completion date January 2016

Study information

Verified date January 2017
Source Cukurova University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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..


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)


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cukurova University

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of postoperative pain by using VAS scale after obturation with different sealers. 72 hour
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