Comparison of Post-operative Pain After Using Different File Systems

NCT06665152 | Completed DMC FDA Device

• 1 other identifier: CMHLMCIOD
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

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.

  6 hours - 72 hours

Study Arms (2)

ProTaper Group

EXPERIMENTAL

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

WaveOne Group

ACTIVE COMPARATOR

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

Interventions

ProTaper File System DEVICE

A rotary file system

ProTaper Group

WaveOne File System DEVICE

A reciprocating file system

WaveOne 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

• Ahmed Abdullah: lead

Study Sites (1)

28 MDC

Lahore, Punjab Province, 54000, 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 Officials

• Nadeem A Rana, BDS, FCPS

  CMH LMC IOD

  STUDY DIRECTOR

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 was also not disclosed the intervention's name; rather, a code name was given to them. 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: SPONSOR 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 74 patients divided into two groups and given different interventional treatment to monitor pain after treatment.

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: October 30, 2024
• Study Start: January 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 18, 2022
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)