Comparison of Postoperative Pain After Root Canal Treatment With Rotary vs Reciprocating Systems

NCT06779565 | Completed DMC

• 1 other identifier: 21MDC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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. The scale is numbered from 1 - 10, with 1 indicating no pain and 10 indicating worst pain imaginable.

  6 hours - 72 hours

Study Arms (2)

Hyflex Group

ACTIVE COMPARATOR

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

Recriproc Group

ACTIVE COMPARATOR

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

Interventions

Hyflex EDM system DEVICE

A rotary file system

Hyflex Group

Reciproc VDW system DEVICE

A reciprocating file system

Recriproc Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Armed Forces Institute of Dentistry, Pakistan: lead

Study Sites (1)

21 MDC

Quetta, Balochistan, 87300, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients did not know which file system was used in their treatment. The investigator also did not disclose the intervention's name; rather, a code name was given to them. The outcomes accessor also did not know the exact name but was provided with a code name.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Comparison of postoperative pain in two groups of patients, who underwent root canal treatment with two different file systems. total 80 patients divided into two groups and given different interventional treatment to monitor pain after treatment.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 16, 2025
• Study Start: August 15, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 10, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)