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Completed

NCT Number: NCT06207019

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

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

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University, Egypt

Tanta, Gharbia Governorate, 31773, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

rotary single files

Primary outcomes

  1. Postoperative pain evaluation

    Time frame: 24 hours to 7 days

    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 fill

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 16, 2024
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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