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Clinical Trials/NCT06207019
NCT06207019
Completed
N/A

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

Tanta University1 site in 1 country30 target enrollmentJanuary 30, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Root Canal Treatment
Sponsor
Tanta University
Enrollment
30
Locations
1
Primary Endpoint
Postoperative pain evaluation
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 30, 2020
End Date
March 5, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abdel Moneim Ahmed Elkalashy

Elkalashy AA

Tanta University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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