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

NCT ID: NCT06207019

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2022-03-05

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

Conditions

Root Canal Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Hyflex EDM

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

rotary single files

The XP-endo Shaper

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

rotary single files

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

rotary single files

Interventions

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

rotary single files

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Abdel Moneim Ahmed Elkalashy

Elkalashy AA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdel Moneim A. Elkalashy, Assis.lecturer

Role: PRINCIPAL_INVESTIGATOR

Assis.lecturer at endodontic department

Locations

Faculty of Dentistry, Tanta University, Egypt

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

#R-END-1-20-5

Identifier Type: -

Identifier Source: org_study_id