Postoperative Pain Associated With Three Endodontic Rotary Systems

Acute Pulpitis Clinical Trial

Official title:

Evaluation of Postoperative Pain After Single Visit Root Canal Treatment Associated With The Three Rotary Systems; ONE ENDO, F6 SkyTper and ProTaper Universal. (Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03065777
• Other study ID #: CEBC-CU-2016-11-173
• Status: Recruiting
• Phase: N/A
• First received: February 15, 2017
• Last updated: February 22, 2017
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: Cairo University
• Contact: Ola A. Hafez, MD Student
• Phone: 0021111626076
• Email: olahafez2010[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of postoperative pain after root canal treatment using different rotary systems.

Description:

Randomized controlled clinical trial comparing three types of endodontic rotary files to assess their effect on postoperative pain after single visit root canal treatment of premolar teeth diagnosed with acute irreversible pulpitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Systematically healthy patients,

• maxillary or mandibular premolar teeth with acute irreversible pulpitis and indicated for conventional endodontic treatment.

Exclusion Criteria:

• Non-vital teeth,

• teeth with apical periodontitis,

• teeth requiring endodontic retreatment,

• root resorption,

• immature / open apex,

• root canals with radiographic evidence of calcification,

• presence of more than one symptomatic tooth in the same quadrant,

• pregnancy,

• medically compromised patients,

• patients receiving medication for chronic pain,

• patients who have taken analgesics in the last 12 hours before treatment.

• teeth that have initial apical size more than 20,

• teeth that could not be treated in a single session,

• if any evidence of extrusion of root filling material noticed radiographically, patient will be excluded.

Related Conditions & MeSH terms

• Acute Pulpitis
• Pain, Postoperative
• Pulpitis

Intervention

Device:
• ONE ENDO
single file rotary system
• F6 SKYTaper
single file rotary system
• ProTaper Universal
multi-file rotary system

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	Verbal Rating Scale (VRS) with the following scores: 0. No pain.; Mild pain: any discomfort of any duration that does not require analgesics.; Moderate pain: pain that requires and is relieved with analgesics.; Severe pain: any pain that is not relieved with analgesics.	up to 72 hours after endodontic treatment
Secondary	Number of analgesics consumed		up to 72 hours after endodontic treatment