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

Root Canal Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06207019
• Other study ID #: #R-END-1-20-5
• Status: Completed
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: March 5, 2022

Study information

• Verified date: January 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 5, 2022
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Root Canal Treatment

Intervention

Device:
• Hyflex EDM , The XP-endo Shaper, Primary WaveOne Gold
rotary single files

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Tanta University, Egypt	Tanta	Gharbia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain evaluation	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	24 hours to 7 days