Postoperative Pain of Root Canal Therapy With Three Techniques

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442388
• Other study ID #: 9308
• Status: Completed
• Phase: N/A
• First received: May 7, 2015
• Last updated: May 8, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this prospective, randomized, double-blind study was to compare the prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical lesion using three different instrumentation files: Hand, Protaper Universal, and Wave-One files.

Description:

ProTaper Universal system is one of the conventional multi-file rotary systems that prepared root canals with six files: three shaping files and three finishing files. A unique design element is varying tapers along the instruments' long axes. The three shaping files have tapers that increase coronally, and the reverse pattern is seen in the five finishing files. Wave-One is reciprocation-based systems that instrumented root canals with only single file. Some studies demonstrated that it has outperformed conventional continuous rotary nickel-titanium (NiTi) preparation in some aspects. The reciprocating motion of Wave-One relieves the stress on the file by special counterclockwise (cutting action) and clockwise (release of the instrument) movements and, therefore, extends the durability of a NiTi instrument and increases its fatigue resistance in comparison with continuous rotation motion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy patient

Exclusion Criteria:

• Allergy to anesthetics, pregnancy, breastfeeding, vital teeth, unrestorable teeth, and teeth associated with pain or swelling

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Instrumentation technique with hand file
type of instrumentation technique for root canal treatment
• Instrumentation technique with ProTaper
type of instrumentation technique for root canal treatment
• Instrumentation technique with WaveOne
type of instrumentation technique for root canal treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as assessed by Heft-Parker VAS	Pain as assessed by Heft-Parker VAS	After each technique, up to 72 hours	Yes