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Postoperative Pain After Using Different Single-File Glide Path Systems

Evaluation of Postoperative Pain After Using Different Single-File Glide Path Systems: a Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05955742
Enrollment
78
Registered
2023-07-21
Start date
2019-06-27
Completion date
2021-09-15
Last updated
2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Keywords

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

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.

Detailed description

Pain after root canal treatment is an important complication encountered in endodontic practice, with a reported prevalence of 3%-58%. Severe pain may start even 24 to 48 h after treatment. Postoperative pain has a complex etiology, including treatment factors under the control of the clinician, microbial factors related to the contents of infected root canals, patient demographic factors (patient sex and age, among others), immunological factors, local tissue changes, and psychological factors. Debris extrusion to the periapical tissues during root canal instrumentation can significantly influence the incidence and intensity of postoperative pain. The root canal instrumentation technique may play an important role in the occurrence of postoperative pain as it can induce an acute inflammatory response following periapical extrusion of necrotic tissues, infected debris, and bacteria. Previous clinical trials have evaluated the effect of reciprocation and continuous rotation kinematics on debris extrusion and postoperative pain; however, their results are conflicting. The glide path is defined as a straight tunnel extending from the canal orifice to the physiological apical foramen. Glide-path preparation may prevent complications of root canal instrumentation; reduce risk of instrument failure, debris extrusion, and postoperative pain; and preserve root canal anatomy, thereby reducing the risk of transportation, perforation, and step and zip formation. Many NiTi glide-path file systems of different sizes and metallurgical properties have been introduced to date. Recently, a new single glide-path file system was introduced with the aim of reducing the number of files used and simplifying glide-path instrumentation. The effect of glide-path file systems on postoperative pain has been studied previously. However, to the best of investigators' knowledge, there are no data comparing PG and WOGG glide-path files in terms of postoperative pain in asymptomatic teeth with necrotic pulp and periapical lesions. Therefore, the purpose of this in vivo study was to evaluate the incidence and intensity of postoperative pain in asymptomatic maxillary and mandibular molars with necrotic pulp and periapical lesions after glide-path preparation with a stainless-steel K-file and PG and WOGG glide-path file systems. The null hypothesis was that there is no difference in the incidence and intensity of postoperative pain between glide-path preparation techniques.

Interventions

DEVICEControl

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

DEVICEProGlider

The operator prepared the glide path using the ProGlider file.

DEVICEWaveOne Gold Glider

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

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain intensity following the use of different glide path preparations6th hourPostoperative 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026