Postoperative Pain After Using Different Single-File Glide Path Systems

NCT05955742 | Completed

• 1 other identifier: EskisehirOU-endodonti
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate postoperative pain intensity after glide-path preparation with the ProGlider (PG) and WaveOne Gold Glider (WOGG) systems in asymptomatic teeth with necrotic pulp and periapical lesions.Maxillary and mandibular molars with chronic apical periodontitis of 78 patients (age, 18-65 years) were included. The patients were randomly divided into three groups: control (n = 26), PG (n = 26), and WOGG (n = 26). All systems were used according to the manufacturer's instructions, and all root canal treatments were completed by a single operator within two sessions. Postoperative pain was assessed using a numerical rating scale (NRS) at 6, 12, 18, 24, 48, and 72 h. The intake of prescribed analgesics and abscess formation were also recorded.

Conditions

Post Operative Pain

Keywords

chronic apical periodontitis; glide path preparation; Postoperative pain; ProGlider; WaveOne Gold Glider

Outcome Measures

Primary Outcomes (6)

• Postoperative pain intensity following the use of different glide path preparations

  Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.

  6th hour

• Postoperative pain intensity following the use of different glide path preparations

  Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.

  12th hour

• Postoperative pain intensity following the use of different glide path preparations

  Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.

  18th hour

• Postoperative pain intensity following the use of different glide path preparations

  Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.

  24th hour

• Postoperative pain intensity following the use of different glide path preparations

  Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.

  48th hour

• Postoperative pain intensity following the use of different glide path preparations

  Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.

  72nd hour

Study Arms (3)

Control

EXPERIMENTAL

Glide path preparation with hand files.

Device: Control

ProGlider

EXPERIMENTAL

Glide path preparation using rotational NiTi file.

Device: ProGlider

WaveOne Gold Glider

EXPERIMENTAL

Glide path was preparation using reciprocating NiTi file.

Device: WaveOne Gold Glider

Interventions

Control DEVICE

The operator prepared the glide path using a #15K-type stainless-steel hand file.

Control

ProGlider DEVICE

The operator prepared the glide path using the ProGlider file.

ProGlider

WaveOne Gold Glider DEVICE

The operator prepared the glide path using the WaveOne Gold Glider file.

WaveOne Gold Glider

Eligibility Criteria

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

You may qualify if:

• Asymptomatic maxillary and mandibular first and second molars diagnosed with chronic apical periodontitis in healthy patients
• Patients between 18-65 years old
• Patients who had not taken antidepressants, sedative drugs, analgesics and/or anti-inflammatory drugs
• Patients who could understand the use of numeric rating scale (NRS) for pain.

You may not qualify if:

• Patients who were allergic to anesthetics and non-steroidal drugs
• Patients who use immunosuppressants
• Patients who are pregnant or breastfeeding
• Patients with systemic infections.
• Teeth with advanced periodontal disease
• Teeth with acute pain
• Teeth with calcified or resorbed canals
• Teeth with complex root canal anatomy
• Teeth with vital pulp
• Unrestorable teeth
• Presence of cracks and/or fractures
• Teeth associated with acute and chronic apical abscesses

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

Related Publications (1)

• Danaci Z, Yeter KY. Evaluation of Pain Following the Use of Different Single-file Glide Path Systems: A Randomized Clinical Trial. J Endod. 2024 Feb;50(2):120-128. doi: 10.1016/j.joen.2023.10.017. Epub 2023 Nov 3.

  PMID: 37924939 DERIVED

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

• Kubra Yesildal Yeter, Assoc. Prof.

  Eskisehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and statistician were blind to the groups but the operator who performed all treatment procedures could not be blinded to the study group owing to the study design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Group 1: control Group 2: ProGlider Group 3: WaveOne Gold Glider

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 21, 2023
• Study Start: June 27, 2019
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)