Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems

March 26, 2018 updated by: Tan Firat Eyuboglu, Istanbul Medipol University Hospital

Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems During Single-Appointment Non-Surgical Endodontic Retreatment: A Randomized Clinical Trial

In this study the effect of different engine-driven nickel titanium (Ni-Ti) instrumentation systems (OneShape, Revo S and WaveOne) on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal retreatment was evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this clinical study was to evaluate the effect of different engine-driven nickel titanium (Ni-Ti) instrumentation systems (OneShape, Revo S and WaveOne) on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal retreatment. A total of a hundred thirty nine patients with asymptomatic teeth and with no contradictory medical history who were indicated for non-surgical retreatment at the Endodontic Clinic, Faculty of Dentistry, Istanbul Medipol University, between September and December 2016 were included in this study. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Out of a hundred thirty nine patients, a total of ninety-nine patients who met the inclusion criteria and agreed to participate was enrolled for the study and were divided into three groups (n=33). Consent was obtained from all study participants before the treatment. After removing previous root canal filling, instrumentation was performed using One Shape, Revo-S, and WaveOne in groups 1, 2, and 3, respectively. All retreatments were performed in a single appointment by one endodontist before permanent coronal restoration. Postoperative pain intensity was assessed at 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month after the retreatment. The teeth was examined according to for pain intensity, percussion & palpation sensitivity, swelling, analgesic intake and clinical status.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asymptomatic teeth
  • Patients with no contradictory medical history
  • Patients who were indicated for non-surgical retreatment and
  • Patients who were above 18 years old

Exclusion Criteria:

  • Patients aged below 18 years;
  • Symptomatic teeth,
  • Teeth with vertical root fractures
  • Teeth with excessive periodontal disease;
  • Patients who received or required surgical endodontic treatment
  • Patients diagnosed with systemic diseases
  • Patients who used analgesics 12 h before or
  • Patients who used antibiotics 1 month before the retreatment

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: single file rotary motion
after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using OneShape Ni-Ti system.
Device: Group 1: single file rotary motion
after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using OneShape Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods
Other Names:
  • OneShape
Active Comparator: Group 2: multiple file rotary motion
after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using Revo S Ni-Ti system.
Device: Group 2: multiple file rotary motion
after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using Revo S Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods
Other Names:
  • Revo S
Active Comparator: Group 3: single file reciprocal motion
after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using WaveOne Ni-Ti system.
Device: Group 3: single file reciprocal motion
after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using WaveOne Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods
Other Names:
  • WaveOne

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Postoperative Pain after single appointment retreatment at 1 month
Time Frame: 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month
The primary outcome measure of the study was to assess if different nickel titanium root canal shaping systems influence the intensity and duration of postoperative pain in single-visit non-surgical root canal re-treatments. Postoperative pain was recorded using a four-level verbal rating scale, where 0 indicated no pain, 1 indicated slight pain, 2 indicated moderate pain, and 3 indicated sever pain. the patients were asked to return to the clinic for assessing postoperative pain (tenderness to palpation and percussion) at 24, 48, and 72 h; 7 days; and 1 month after the treatment. One clinician performed all the assessments at 24, 48, and 72 h; 7 days; and 1 month.
6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
unscheduled appointment for emergency intervention
Time Frame: 1 month
the presence or absence of unscheduled appointment for emergency dental intervention was recorded on the chart of the patient as "present" or "absent" during the observation time
1 month
presence of complications
Time Frame: 1 month
the absence or presence of complications (such as swelling or parasthesia) after the intervention was recorded on the chart of the patient as "present" or "absent" during the observation time
1 month

Collaborators and Investigators

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

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: TAN FIRAT EYUBOGLU, DDS, PhD, Medipol University

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)

September 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 26, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 26, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 481

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.

Clinical Trials on Pain, Postoperative

Clinical Trials on Group 1: single file rotary motion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe