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

Not Applicable

Completed

• Conditions: Root Canal Treatment
• Interventions: Device: Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold

• Registration Number: NCT06207019
• Lead Sponsor: Tanta University

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

Study Timeline

• Study Start: 2020-01-30
• Primary Completion: 2021-01-11
• Study Completion: 2022-03-05
• Status Verified: 2024-01
• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-05
• Last Update Submitted: 2024-01-05
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
The XP-endo Shaper	Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold	The XP-endo Shaper (30/0.01) was used in rotation mode at 800 rpm and 1.0 Ncm torque. Long, gentle strokes with amplitudes of 3-4 mm were used to go down to adjusted WL in three to five cycles. After it reached the WL over the adjusted WL, it was subjected to five more up-and-down motions.
Hyflex EDM	Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold	Hyflex EDM One File (25/) with variable taper was used in continuous rotation at 500 rpm and 2.5 Ncm in a circumferential brushing action in the coronal and middle thirds, then in a pecking action for three to five cycles until the WL was reached.
Primary WaveOne Gold	Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold	Primary WaveOne Gold (25/07) was applied three times in a reciprocating motion; a gradual in-and-out pecking movement was utilized as directed by the manufacturer till the WL was reached.

Primary Outcome Measures

Name	Time	Method
Postoperative pain evaluation	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

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University, Egypt; 🇪🇬 Tanta, Gharbia Governorate, Egypt