Clinical trial NCT06207019: Post-Operative Pain Evaluation After Using Different Single-file Root Canal Preparation System: A Randomized Clinical Study
Official title: Post-Operative Pain Evaluation After Using Different Single-file Root Canal Preparation System: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Treatment
Keywords: Hyflex/EDM; Post-operative pain; Single-file systems; Wave One Gold; XP-endo shaper.
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: Postoperative pain evaluation
timeFrame: 24 hours to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry, Tanta University, Egypt
state: Gharbia Governorate
Study officials:
affiliation: Assis.lecturer at endodontic department
name: Abdel Moneim A. Elkalashy, Assis.lecturer
role: PRINCIPAL_INVESTIGATOR
References: