Comparative Evaluation of Different File Systems in Postoperative Pain

Comparative Evaluation of Different File Systems in Postoperative Pain: Randomize Clinical Study

Postoperative pain is a frequent complication associated with root canal treatment. The apical extrusion of irrigant and debris, including bacteria and necrotic tissue, may lead to postoperative pain, periapical inflammation, and flare-ups. The instrumentation technique and the file design may affect the amount of debris extrusion.

The aim of this study was to evaluate the influence of instrumentation techniques on the incidence and intensity of postoperative pain after single-visit root canal treatment.

Study Overview

• Status: Completed
• Conditions: Pulpitis; Periapical Periodontitis; Necrotic Pulp
• Intervention / Treatment: Procedure: ProTaper Next; Procedure: TF Adaptive

Detailed Description

Sixty patients having root canal treatment indication and a single root canal were included in the study. The patients were randomly assigned into 2 groups according to root canal instrumentation technique used. In group 1; ProTaper Next (Dentsply Maillefer, Ballaigues, Switzerland) instruments with rotational motion, in group 2 TF Adaptive (SybronEndo, Orange, CA) instruments with adaptive motion were used for root canal treatments. Root canal treatment was carried out in a single visit and the severity of postoperative pain was assessed via a four-point pain intensity scale. All the participants were called through the phone at 12, 24 and 48h to obtain the pain scores. Data were analyzed using the Mann Whitney-U, Friedman and Wilcoxon tests.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Zonguldak, Turkey
    • Bülent Ecevit University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients referred to dental clinic for endodontic treatment

Description

Inclusion Criteria:

• having root canal treatment indication
• single root canal

Exclusion Criteria:

• previously treated tooth

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Root canal treatments will be completed by ProTaper Next instruments with rotational motion	Procedure: ProTaper Next; Root canal instrument
Group 2; Root canal treatments will be completed TF Adaptive instruments with adaptive motion.	Procedure: TF Adaptive; Root canal instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain	Postoperative pain which occurs after root canal instrumentation and measured with a commonly used scale named 'four-point pain intensity scale' for pain intensity. Patients were instructed postoperatively to express their pain according to the staed scale ranging between no pain and severe pain. The scale consists of 4 scores ranging between 1-4. The pain categories were as follows; no pain;; mild pain (slight discomfort, no need for treatment);; moderate pain (pain relieved by medication);; severe pain (pain and/or swelling not relieved by simple analgesic medication and unscheduled visit required). For patients having no pain score 1, for patients having slight pain in case of no medication score 2 , and score 3 in case of any requirement of medication due to moderate pain, and score 4 for patients having severe pain with the requirement of an unscheduled visit were accepted. The higher values represent more pain intensity.	2 days

Collaborators and Investigators

• Sponsor: Bulent Ecevit University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): September 10, 2018
• Study Completion (Actual): October 5, 2018

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Dental Pulp Diseases; Periapical Diseases; Pain, Postoperative; Periodontitis; Pulpitis; Periapical Periodontitis; Dental Pulp Necrosis
• Other Study ID Numbers: BEU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No