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Post-Operative Pain Evaluation After Using Different Single-file Root Canal Preparation System: A Randomized Clinical Study

Post-Operative Pain Evaluation After Using Different Single-file Root Canal Preparation System: A Randomized Clinical Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06207019
Enrollment
30
Registered
2024-01-16
Start date
2020-01-30
Completion date
2022-03-05
Last updated
2024-01-16

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

Conditions

Root Canal Treatment

Keywords

Hyflex/EDM; Post-operative pain; Single-file systems; Wave One Gold; XP-endo shaper.

Brief summary

The goal of this clinical trial is to assess post-operative pain following root canal preparation using various single-file systems

Detailed description

The goal of this clinical trial is to assess post-operative pain following root canal preparation using various single-file systems.Postoperative pain assessment was done by an independent evaluator with no knowledge of the group under investigation. The visual Analogue Scale (VAS) was employed. Patients could put a mark anywhere on the VAS sheet with values ranging from 0 to 100 mm \[10\]. * Score 0: No pain (between 0 and 4 mm) the tooth after treatment felt normal, and no discomfort was reported by the patients. * Score 1: Recognizable, mild pain (between 5 and 44 mm), not requiring analgesics. * Score 2: Moderate pain (between 45 and 74 mm) that is uncomfortable but bearable (when analgesics were taken, the pain was successfully reduced). * Score 3: Severe pain (between 75 and 100 mm) painful to endure (pain was not relieved by taking analgesics). The patients in this study were not aware of the preparation system used during treatment. Following treatment, three readings were taken at 24, 72, and 7 days. Each patient carried a VAS form, and reminder calls were made to record pain levels and return the form filled out completely

Interventions

DEVICEHyflex EDM , The XP-endo Shaper, Primary WaveOne Gold

rotary single files

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* • Teeth with a single root canal with nearly the same apical diameter (#15) * Vital pulp exposures due to caries or trauma with asymptomatic pulpitis * Restorable teeth

Exclusion criteria

* • Patients with immune deficiencies or systemic illnesses * Pregnant women * Cases of re-treatment * Symptomatic non-vital teeth that require root canal therapy * Presence of root resorption * Teeth with anatomic variations * A cute periapical abscess cases with pus discharge * A patient who has several teeth that need to be treated in order to eliminate the likelihood of pain referral * Periodontal diseases * Patients on analgesics, anti-inflammatory drugs, sedatives, or antibiotics seven days before therapy

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain evaluation24 hours to 7 daysPostoperative pain assessment was done by an independent evaluator with no knowledge of the group under investigation. The visual Analogue Scale (VAS) was employed. Patients could put a mark anywhere on the VAS sheet with values ranging from 0 to 100 mm \[10\]. • Score 0: No pain (between 0 and 4 mm) the tooth after treatment felt normal, and no discomfort was reported by the patients. • Score 1: Recognizable, mild pain (between 5 and 44 mm), not requiring analgesics. • Score 2: Moderate pain (between 45 and 74 mm) that is uncomfortable but bearable (when analgesics were taken, the pain was successfully reduced). • Score 3: Severe pain (between 75 and 100 mm) painful to endure (pain was not relieved by taking analgesics). The patients in this study were not aware of the preparation system used during treatment. Following treatment, three readings were taken at 24, 72, and 7 days. Each patient carried a VAS form, and reminder calls were made to record pain levels and return the form fill

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026