The Effect of Instrumentation and Obturation on Postoperative Pain in Retreatment

March 4, 2021 updated by: Marmara University

The Effect of Reciprocating Instrument and Obturation Techniques on Postoperative Pain in Retreatment : A Prospective Clinical Study

Objectives: The aim of this study was to assess postoperative pain in prospective randomized clinical trial comparing Reciproc or hand instrument and also different obturation techniques in one visit of endodontic retreatment.

Conventional root canal treatment was done to 45 patients who needed retreatment. All instruments used in this study are routinely used instrument in endodontic therapy. After completed root canal treatment, the patients asked the intense of post operative pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Materials and metods: The study was included 45 patients (18-65 yrs old) who needed endodontic retreatment in mandibular premolar or molar without any symptoms. The teeth had been randomly assign into 3 groups according to the instrumentation or obturation techniques; hand files with lateral condensation, Reciproc with lateral condensation, or Reciproc with continuous condensation technique. Retreatments had performed in a single visit. Coronal restorations were removed, the gutta-percha were extracted using either Reciproc or hand files. After, biochemical and mechanical praparation, the canals were filled with gutta-percha cones and AH Plus sealer using the lateral condensation or continuous wave of obturation technique. Participants were been asked to rate the incidence and intensity of the postoperative pain on a verbal rating scale 24h, 48h and 72h and 7 days after retreatment. All data were analyzed using (Chi-square test, p=0,05)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Istanbul, Turkey, 34854
        • Marmara University Faculty of Dentistry, Basibuyuk Campus, Maltepe

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who had previosly done unacceptable root canal treatment on lower premolar or molar with no pain.

No medication should be taken 10 days before treatment for any reason ( such as corticosteroid, antibiotics or analgesic )

Exclusion Criteria:

  • age less than 18 or over 65,pregnancy nonrestorable tooth other than lower molar or premolar tooth with more than 4mm periodontal pocket root with broken instrument or any post

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: hand files with lateral condensation technique
Previously done root canal filling removed by hand files (Hedstrom file,VDW, Munich,Germany ) and shaped with the same files and after instrumentation, all canals were filled by AH Plus sealer (Dentsply De Tray, Costanz, Germany) and lateral condensation technique of gutta-percha.
Other: Root canal treatment
The patient usually takes anaesthesia before treatment and access cavity was prepared on the tooth and root canal removed and instrumented and obturated. However, in the present study, previously done root canal was retreated. Usually no anaesthesia was used because all root canals were done before. So just instrumentation and obturation was done.
Experimental: Reciproc instrument with lateral condensation technique
Previous root canal filling removed by Reciproc instrument (VDW ,Munich, Germany )using Endomotor (VDW, Munich, Germany). After removal, root canal instrumented with the same instrument and obturated using AHPlus sealer with lateral condensation technique of gutta-percha.
Other: Root canal treatment
The patient usually takes anaesthesia before treatment and access cavity was prepared on the tooth and root canal removed and instrumented and obturated. However, in the present study, previously done root canal was retreated. Usually no anaesthesia was used because all root canals were done before. So just instrumentation and obturation was done.
Experimental: Reciporoc instrument with continuous warmed condensation technique
Previous root canal removed by Reciproc instrument using Endomotor, shaped and obturated by AhPlus sealer with continuous gutta-percha technique (Diadent Dia-Duo (Diadent, Chongju, Korea).
Other: Root canal treatment
The patient usually takes anaesthesia before treatment and access cavity was prepared on the tooth and root canal removed and instrumented and obturated. However, in the present study, previously done root canal was retreated. Usually no anaesthesia was used because all root canals were done before. So just instrumentation and obturation was done.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: 24 hours.
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
24 hours.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post operative pain; change is being assessed.
Time Frame: 48 hours
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
48 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post operative pain; change is being assessed.
Time Frame: 72 hours.
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
72 hours.
post operative pain; change is being assessed.
Time Frame: 7 days.
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
7 days.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hesna Sazak Ovecoglu, DDS, PhD, Marmara University Faculty of Dentistry Department of Endodontics

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAG-C-DUP-170419-0144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All statistical datas was documented in post doctorate thesis and will be available at www.tez.gov.tr in a month. Also will be send for publication in one of the dental journal.

IPD Sharing Time Frame

Approximately 1 month later in www.tez.gov.tr

IPD Sharing Access Criteria

by the title of the study or the name of the researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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