Comparative Evaluation of Different File Systems in Postoperative Pain

Completed

• Conditions: Necrotic Pulp; Pulpitis; Periapical Periodontitis
• Interventions: Procedure: TF Adaptive; Procedure: ProTaper Next

• Registration Number: NCT03708081
• Lead Sponsor: Bulent Ecevit University

Brief Summary

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.

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 Timeline

• Study Start: 2017-06-01
• Primary Completion: 2018-09-10
• Study Completion: 2018-10-05
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• having root canal treatment indication
• single root canal

Exclusion Criteria

• previously treated tooth

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	TF Adaptive	Root canal treatments will be completed TF Adaptive instruments with adaptive motion.
Group 1	ProTaper Next	Root canal treatments will be completed by ProTaper Next instruments with rotational motion

Primary Outcome Measures

Name	Time	Method
Post operative pain	2 days	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; 1. no pain; 2. mild pain (slight discomfort, no need for treatment); 3. moderate pain (pain relieved by medication); 4. 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.

Trial Locations

Locations (1)

Bülent Ecevit University, Faculty of Dentistry; 🇹🇷 Zonguldak, Turkey