Incidence of Postoperative Pain After Root Canal Preparation Using Three Different Instruments

NCT03791762 | Completed

• 1 other identifier: KAEK/389
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In an ideal endodontic treatment, maintenance of the original root canal morphology of the canal during root canal preparation, an ideal preparation and obturation is essential. Even if all stages are ideal, pain after endodontic treatment is a clinical condition that may occur after a few hours or several days. Post-operative pain after endodontic treatment is an undesirable condition which makes the clinician and the patient a distressing condition. Many clinical studies reported a 25-40% postoperative pain rate after endodontic treatment, which means that postoperative pain is a clinical symptom that should be considered for endodontist. The ProTaper Next files (Dentsply Tulsa Dental Specialties) operate in continuous rotary motion, and their center of mass or center of rotation is positioned off-center relative to the instrument's central axis of rotation. During rotation, the files of this design produce a mechanical wave of motion, which travels along the length of the working part of the instrument, minimizing the contact between the file and dentin. According to the manufacturer, the offset design of this instrument also improves debris removal and flexibility in the working part of the file. New heat treatment has been carried out on NiTi alloy, seeking to increase its flexibility and cyclic fatigue resistance. Recently, the Wave One Gold instrument, manufactured with a new thermal treatment called Gold treatment, was introduced on the market presenting some differences in design, size and taper compared to Wave One. Wave One Gold instrument has a parallelogram cross-sectional design, having two cutting edges, and consists of four instruments, 21/.06 (small), 25/07 (primary), 35/06 (medium) and 45/05 (large) while Wave One presents convex triangular cross-sectional design, besides larger size and taper. Reciproc blue (REB, VDW), a new-generation reciprocating single-file system, is the latest version of REC. Like the REC file, REB also has an S-shaped cross section, 2 cutting edges, and a noncutting tip. However, REB files are manufactured by altering the molecular structure through a new heat treatment in order to increase the cyclic fatigue resistance. This new heat treatment gives the file its blue color. It was reported that REB files have approximately 2 times higher cyclic fatigue resistance than REC files. In addition, REB files can also be relatively prebent to better access curved canals. However, the effect of Reciproc Blue, Protaper Next, Waveone Gold within preparation on the postoperative endodontic pain has not been investigated, yet. The aim of this prospective clinical trial was to clinically compare the incidence of postoperative pain after use of different nickel titanium file systems. The purpose of the present study was to evaluate the incidence of postoperative pain root canal preparation performed with Reciproc Blue, Protaper Next, Waveone Gold. The null hypothesis tested was that there is no difference in the incidence and severity of postoperative pain following with any of the 3 instruments.

Conditions

Postoperative Pain

Keywords

postoperative pain; WaveOne Gold; Reciproc Blue; ProTaper Next

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Scores using Visual Analogue Scale

  Visual analogue scale is a measure of pain intensity. In the present study, the visual analogue scale included a 10 cm straight horizontal line numbered at each centimetre from 0 to 10 showing two extreme symptoms of pain. "0" means no pain and "10" means the worst pain the subject has ever experienced. Each centimeter represents the pain intensity that the subject will mark orientated from 0 to 10. The intensity is increased from 0 to 10, therefore a higher score means a higher pain intensity and a worse outcome. 1-3 means "mild pain", 4-6 means "moderate pain" and 7-9 means "severe pain". There are no subscales.

  72 hours

Study Arms (3)

WaveOne Gold

EXPERIMENTAL

Root canal preparation with WaveOne Gold instrumentation system in a reciprocating manner

Procedure: WaveOne Gold

Reciproc Blue

EXPERIMENTAL

Root canal preparation with Reciproc Blue instrumentation system in a reciprocating manner

Procedure: Reciproc Blue

ProTaper Next

EXPERIMENTAL

Root canal preparation with ProTaper Next instrumentation system in a rotating manner

Procedure: ProTaper Next

Interventions

WaveOne Gold PROCEDURE

WaveOne Gold was operated by an endomotor (VDW Gold, Munich, Germany) at "WaveOne ALL" setting.

Also known as: Reciprocating root canal preparation instruments, Dentsply Sirona, Ballaigues, Switzerland

WaveOne Gold

Reciproc Blue PROCEDURE

Reciproc Blue was operated by an endomotor (VDW Gold, Munich, Germany) at "Reciproc ALL" setting.

Also known as: Reciprocating root canal preparation instruments, VDW, Munich, Germany

Reciproc Blue

ProTaper Next PROCEDURE

ProTaper Next was operated by an endomotor (VDW Gold, Munich, Germany) with 16:1 contra angle at the settings suggested by the manufacturer (350 rpm, 3 Ncm).

Also known as: Rotating root canal preparation instrument, Dentsply Sirona, Ballaigues, Switzerland

ProTaper Next

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with no systemic disease or condition
• Patients having a maxillary or mandibular teeth diagnosed with one of the plural and periodontal diseases (asymptomatic irreversible pulpitis, symptomatic irreversible pulpitis, symptomatic apical periodontitis or asymptomatic apical periodontitis)

You may not qualify if:

• Patients, who were diagnosed with acute or chronic apical abscesses
• Patients showing signs of systemic infection
• Patients with allergies to local anesthetic agents,
• Patients who are taking medication (analgesic, antibiotic or anti-inflammatory drugs) during the 7 days before the procedure
• Patients presenting with multiple teeth requiring treatment or having a progressive periodontal disease

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Özlem Yilmaz

Samsun, 55400, Turkey (Türkiye)

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 3, 2019
• Study Start: May 1, 2018
• Primary Completion: December 25, 2018
• Study Completion: December 27, 2018
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

TU (1)