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

NCT06207019 | Completed

• 1 other identifier: #R-END-1-20-5
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Root Canal Treatment

Keywords

Hyflex/EDM; Post-operative pain; Single-file systems; Wave One Gold; XP-endo shaper.

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Hyflex EDM

ACTIVE COMPARATOR

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.

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

The XP-endo Shaper

ACTIVE COMPARATOR

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.

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

Primary WaveOne Gold

ACTIVE COMPARATOR

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.

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

Interventions

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

rotary single files

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

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University, Egypt

Tanta, Gharbia Governorate, 31773, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Abdel Moneim A. Elkalashy, Assis.lecturer

  Assis.lecturer at endodontic department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elkalashy AA

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 16, 2024
• Study Start: January 30, 2020
• Primary Completion: January 11, 2021
• Study Completion: March 5, 2022
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

EG (1)