Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems

Assessment of Postoperative Pain After Using 2Shape and Protaper Next Rotary Systems in Patients With Symptomatic Pulpitis in Mandibular Molars:A Randomized Clinical Trial

Pain after endodontic treatment is considered the most disturbing problem facing both the patient and the dentist especially in cases of symptomatic pulpitis as the patient is expecting to relief the pain that already exists.Therefore, this study aims to find a solution for the post-operative pain felt by the patient with symptomatic pulpitis in mandibular molars through comparing post-operative pain following use of 2Shape and Protaper Next rotary systems.

Study Overview

• Status: Unknown
• Conditions: Pulpitis
• Intervention / Treatment: Device: 2Shape rotary system

Detailed Description

Root canal preparation is the most important step in endodontic treatment. For successful treatment, pulp tissue, dentin debris and microorganisms should be completely eradicated from the root canal system.However, it has been reported that all the instrumentation techniques (manual or mechanical) cause debris extrusion into the periradicular tissue resulting in periapical inflammation that causes post-operative pain and flare up.

Instrumentation technique and instrument design were found to be related to the amount of debris extruded which is the main cause of post-operative pain. It has been reported that rotary NiTi systems cause less debris extrusion than manual instrumentation.

Within NiTi systems, instrument design, taper and tip size were found to affect debris extrusion. Therefore, new innovations in the instrument designs are introduced in order to reduce post-operative pain and flare up incidence.

Therefore, this study is established to compare the effect of 2 different rotary systems on postoperative pain in patients with symptomatic pulpitis.

The aim of the present study is to assess the effect of rotary instrumentation using Protaper Next rotary system versus 2Shape rotary system on postoperative pain and the number of analgesics taken by the patient following single visit root canal treatment in mandibular molars with symptomatic pulpitis.

Primary objective:

Comparing the intensity of post-operative pain using Numerical Rating Scale (NRS) immediately after root canal treatment and post-appointment at 6, 12, 24, 48 and 72hours.

Secondary objectives:

• The need for / and number of analgesic tablets taken within 3 days after end of endodontic treatment.
• Instrument separation during instrumentation.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• - Medically free patients.
• Patients with symptomatic pulpitis in one of their mandibular molars.
• Patient's age ranges between 22 to 45 years with no sex predilection.
• Patients who can understand Numerical Analogue Scales (NRS).
• Patients able to sign informed consent.

Exclusion Criteria:

• - Patients having a systemic disorder.
• Presence of periapical lesion.
• Pregnant females.
• Patients who had taken analgesics during the last 12 hours preoperatively.
• Patients having active pain in more than one tooth.
• Non- educated patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2Shape rotary system; root canal preparation using 2Shape rotary system in mandibular molars with symptomatic pulpitis	Device: 2Shape rotary system; root canal preparation
Active Comparator: Protaper Next rotary system; root canal preparation using Protaper Next rotary system comparing to 2Shape rotary system in mandibular molars with symptomatic pulpitis	Device: 2Shape rotary system; root canal preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intensity of postoperative pain assessed by numerical rating scale Immediately after the end of treatment, and at 6, 12, 24, 48, and 72 hours. post-operative pain	using numerical rating scale ranges between (0-10) where 0 indicates no pain while 10 indicates maximum pain degree	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for / and number of analgesic tablets taken.	incidence and number of analgesic tablets will be recorded	3 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of instrument seperation during endodontic treatment (instrument seperation means instrument fracture)	incidence will be recorded	1 day

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: September 29, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: mandibular molars
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: dentistry cairo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No