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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03488836
Other study ID # 911150105
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received February 4, 2018
Last updated April 4, 2018
Start date May 2, 2018
Est. completion date November 2, 2018

Study information

Verified date April 2018
Source Hormozgan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

extrusion of infected dentin into the periapical tissue has been suggested as a major source of pain after endodontic treatment. Although debris extrusion is an inevitable finding even when instrumentation is limited to the confines of the canal, different armamentarium seem to be associated with different amounts of debris extrusion. Studies on the effect of various rotary files on post-endodontic pain are very few and have yielded conflicting results with some favoring full-sequence and others leaning towards reciprocal rotary systems. This study aims at assessing the intensity of post-endodontic pain following two different rotary systems, Reciproc and race.

Methods: in this single-blind, parallel-grouped randomized clinical trial a total of 150 otherwise healthy patients aged between 20 to 50 years old with a pulpal status of irreversible pulpitis for one tooth in the upper or lower molar region were analyzed. A clinician performed the endodontic treatment in two groups, a group instrumented using race and a third group with instrumentation performed using Reciproc rotary systems.


Recruitment information / eligibility

Status Recruiting
Enrollment 132
Est. completion date November 2, 2018
Est. primary completion date July 2, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Inclusion criteria: the otherwise healthy patients were aged between 20 to 50 years old with a pulpal status of irreversible pulpitis for one tooth in the upper or lower molar region.

Exclusion Criteria:

- Exclusion criteria: previous endodontic treatment; a history of drug intake including corticosteroids; opioids and NSAIDs in the previous 12 hours; pregnancy; complicated anatomy (curves greater than 25 degrees); calcifications; internal & external resorption; open apices; periodontal disease; swelling & abscess; presence of periapical lesions; sensitivity to percussion and lack of occlusal contact.

Study Design


Intervention

Procedure:
reciproc
rotary reciprocating protocol
race rotary
race rotary group protocol

Locations

Country Name City State
Iran, Islamic Republic of Dental clinic of BandarAbbas faculty of dentistry Bandar Abbas Hormozgan

Sponsors (1)

Lead Sponsor Collaborator
Sajad Ansari Fard

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of the Visual analogue scale change of the vas evaluation 6-12-18-24-48-72 hours
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