Postoperative Pain After Root Canal Preparation Using Different Engine-driven Systems

June 30, 2020 updated by: Gözde Kandemir Demirci, Ege University

Postoperative Pain Incidence of Asymptomatic Mandibular Molar Teeth After Using Different Engine-driven Systems

A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to compare the effect of root canal preparation techniques on the occurrence and intensity of postoperative pain in patients with asymptomatic mandibular molar teeth with periapical lesions.A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.For the comparison of pain scores between the tested instrumentation systems, the Mann Whitney test was used. Differences between postoperative pain intencity for each instrumentation technique, at different time intervals, were assessed by the Friedman test. For the association of pain and an analgesic intake with gender, the chi-square test was performed. For the association of pain with age and an analgesic intake were calculated using Mann Whitney test. A P value < .05 or less was considered significant.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35100
        • Gözde Kandemir Demirci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients without systemic diseases
  • Patients who had a mandibular first molar with asymptomatic periapical lesion without previous endodontic treatment with no sensitivity to percussion
  • Patients who had no spontaneous pre-treatment pain
  • Patients not having taken any analgesics, antibiotics or corticosteroids before the treatment visit,
  • Patients who had no allergic reaction to NaOCl and no intolerance to nonsteroidal anti-inflammatory drugs.

Exclusion Criteria:

  • Patients who had severe periodontal disease
  • The teeth with previous endodontic treatment
  • The teeth with root canal calcification, root resorption
  • The teeth that could not be isolated with rubber dam or were not suitable for further restoration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rotary Engine-driven Instruments
The instrumentation protocol with Protaper Universal rotary files was began with an S1 file with a brushing movement to the two thirds of the working length and then an SX file was introduced to the two thirds of the working length with a brushing movement Afterwards, S1, S2, F1, F2 files in mesial roots and F4 files in distal roots were used to the working length, respectively. Protaper F2 instrument was then used to complete the canal preparation in mesial roots and Protaper F4 instrument was used to complete the canal preparation in distal roots.
Other: Protaper Universal instruments
Root canal treatment using Protaper Universal instruments
Active Comparator: Reciprocal Engine-driven Instruments
The instrumentation of the root canal in the Reciproc Blue group began with a R25 instrument with a slow in-and-out pecking movement.According to the manufacturer instructions, a #10 K-file was inserted to the canal to check the canal is free to 1 mm beyond the prepared canal section. After each 3 pecks or when a resistance was encountered the instrument was pulled out of the canal. Afterward, the R25 instrument was inserted in to root canal until approximately two thirds of the working length.RB R25 instrument was then used to complete the canal preparation in mesial roots and RB R40 instrument was used to complete the canal preparation in distal roots.
Other: Reciproc Blue instruments
Root canal treatment using Reciproc Blue instruments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative pain
Time Frame: 6-hour to 7-day
Postoperative pain after 6, 12, 24, 48, 72 hours and 7 days after obturation was measured using a modified 4-grade visual analogue scale (VAS) ranging from 1(no pain), 2(mild pain), 3 (moderate pain/pain relieved by analgesics), to (4) severe pain.
6-hour to 7-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Gözde Kandemir Demirci, Ege University Faculty of Dentistry
  • Study Chair: Seniha Miçooğulları Kurt, Ege University Faculty of Dentistry
  • Study Chair: Burcu Serefoglu, Ege University Faculty of Dentistry
  • Study Chair: Mehmet E Kaval, Ege University Faculty of Dentistry
  • Study Chair: Mehmet K Çalışkan, Ege University Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2017

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

February 15, 2020

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-6/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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