Comparison of Post-operative Pain After Using Different File Systems

Comparison of Postoperative Pain After Root Canal Preparation With Reciprocal (WaveOne) Versus Continuous Rotary (ProTaper Gold) For Asymptomatic Irreversible Pulpitis

To compare the postoperative pain in patients undergoing root canal instrumentation with two different file systems, WaveOne and ProTaper systems.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Device: ProTaper File System; Device: WaveOne File System

Detailed Description

Endodontic postoperative pain is experienced after the procedure of root canal. It is defined as an unpleasant sensation, of varying degree, 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 shape of the root canal. The debris produced by these instruments is potentially lesser than the manual files. Mainly because they have rotary action and they 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. WaveOne 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.

Relation between debris extrusion and postoperative care has not been established in any previous study. This study is aimed at comparing the use of ProTaper Universal and WaveOne system, for preparation of permanent human teeth during root canal procedure and their effect on postoperative pain.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • 28 MDC

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ProTaper Group; These patients underwent root canal treatment due to pain in their molar teeth. The file system used in this arm was ProTaper (Dentsply), a rotary file system that moves in a complete 360° rotation and prepares a root canal.	Device: ProTaper File System; A rotary file system
Active Comparator: WaveOne Group; These patients underwent root canal treatment due to pain in their molar teeth. The file system used in this arm was WaveOne(Dentsply), a reciprocating file system that moves in 150° anticlockwise and 30° clockwise motion and prepares a root canal.	Device: WaveOne File System; A reciprocating file system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain	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.	6 hours - 72 hours

Collaborators and Investigators

• Sponsor: Ahmed Abdullah
• Investigators: Study Director: Nadeem A Rana, BDS, FCPS, CMH LMC IOD

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 18, 2022

Study Registration Dates

• First Submitted: October 26, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: CMHLMCIOD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data to not be disclosed due to privacy reasons and data sharing for statistical analysis to be done with codenames.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes