Comparison of Postoperative Pain After Root Canal Treatment With Rotary vs Reciprocating Systems (Post op pain)

January 13, 2025 updated by: Ahmed Abdullah, Armed Forces Institute of Dentistry, Pakistan

Comparative Evaluation of Postoperative Pain After Root Canal Preparation With Rotary (Hyflex EDM) vs Reciprocating (Reciproc VDW) System in Molar Teeth: A Randomized Controlled Trial

To compare the postoperative pain in patients undergoing root canal instrumentation with two different file systems, Hyflex EDM and Reciproc VDW.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endodontic postoperative pain is experienced after the procedure of the root canal. It is defined as an unpleasant sensation, of varying degrees, experienced by the patients. Depending upon the individual and other variable, the range of postoperative pain lies between 3% to 58%. Endodontic postoperative pain could occur due to various factors that can be microbial, injured pulp, chemical, or mechanical. Factors that influence pain following a root canal include the presence of preoperative pain, apical debris extrusion, intracanal interappointment dressing extrusion, presence of periapical pathosis, hyper occlusion, and irrigant extrusion.

Although apically extruded debris can be reduced through various means, it cannot be completely avoided. Thus, increasing the incidence of postoperative pain in patients. The debris produced during apical extrusion contains necrotic tissue, dental chips, microbes, pulp tissue, and canal irrigants. The infected debris may disturb the balance between the microbes and the immune system, leading to acute exacerbation.

Manual steel K files tend to produce more debris, causing a high risk of postoperative discomfort. Nickel-titanium rotary instruments powered by the engine have various advantages including; time-saving, preservation of root canal anatomy, and homogeneous preparation of the root canal shape. The debris produced by these instruments is potentially lesser than the manual files. Mainly because they have rotary action and excavate the debris with the help of their flutes. Repeated irrigation along with the action of an engine-driven instrument, has the potential to decrease postoperative pain. Reciproc VDW reciprocating file instruments have potential advantages including reduced fatigue, resistance to fracture, less debris extrusion, good shaping ability, no cross-contamination (single use), and reduced cost.

No previous study has established a relationship between debris extrusion and postoperative care. This study aims to compare the use of the Hyflex EDM and Reciproc VDW systems for preparing permanent human teeth during root canal procedures and their effect on postoperative pain.

Study Type

Interventional

Enrollment (Actual)

80

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

  • Pakistan
    • Balochistan
      • Quetta, Balochistan, Pakistan, 87300
        • 21 MDC

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients with unremarkable/ noncontributory medical history
  2. Healthy persons between the ages of 18 and 60 years
  3. Maxillary and mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
  4. Patients not having taken any medication for 6 hours before treatment
  5. No allergies to the drugs or dental material being used in the treatment

Exclusion Criteria:

  1. Patients who had taken analgesics on anti-inflammatory drugs within the last 12 hours
  2. Pregnant women and patients with immunocompromised health state
  3. Patients having severe malocclusion associated with traumatic occlusion
  4. Teeth with calcified canals
  5. Teeth with periapical radiolucency
  6. Teeth with root resorption
  7. Teeth previously undergone root canal treatment

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hyflex Group
These patients underwent root canal treatment due to pain in their molar teeth. The file system used in this arm was Hyflex EDM (Coltene), a rotary file system that moves in a complete 360° rotation and prepares a root canal.
Device: Hyflex EDM system
A rotary file system
Active Comparator: Recriproc Group
These patients underwent root canal treatment due to pain in their molar teeth. The file system used in this arm was Reciproc (VDW), a reciprocating file system that moves in 130° anticlockwise and 50° clockwise motion and prepares a root canal.
Device: Reciproc VDW system
A reciprocating file system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Pain
Time Frame: 6 hours - 72 hours
Document and compare post-operative pain after root canal treatment, after using two different motorized file systems with different mechanisms. The Visual Analog scale (VAS) would be used to assess the pain. The patients would be guided in detail about the VAS scoring system and mark pain according to the readings on VAS. The scale is numbered from 1 - 10, with 1 indicating no pain and 10 indicating worst pain imaginable.
6 hours - 72 hours

Collaborators and Investigators

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

Sponsor

Armed Forces Institute of Dentistry, Pakistan

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)

August 15, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 10, 2025

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21MDC

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

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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