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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03694743
Collaborator
(none)
44
2
22

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 2Shape rotary system
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Assessment of Postoperative Pain After Using 2Shape and Protaper Next Rotary Systems in Patients With Symptomatic Pulpitis in Mandibular Molars:A Randomized Clinical Trial
Anticipated Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Oct 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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 [3 days]

    using numerical rating scale ranges between (0-10) where 0 indicates no pain while 10 indicates maximum pain degree

Secondary Outcome Measures

  1. Need for / and number of analgesic tablets taken. [3 days]

    incidence and number of analgesic tablets will be recorded

Other Outcome Measures

  1. incidence of instrument seperation during endodontic treatment (instrument seperation means instrument fracture) [1 day]

    incidence will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heba Ibrahim Mohamady, Ass.lecturer of endodotics, Cairo University
ClinicalTrials.gov Identifier:
NCT03694743
Other Study ID Numbers:
  • dentistry cairo
First Posted:
Oct 3, 2018
Last Update Posted:
Oct 3, 2018
Last Verified:
Sep 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Heba Ibrahim Mohamady, Ass.lecturer of endodotics, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2018