Comparative Evaluation of Different File Systems in Postoperative Pain

Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708081
• Other study ID #: BEU
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: October 5, 2018

Study information

• Verified date: December 2018
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 5, 2018
• Est. primary completion date: September 10, 2018
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• having root canal treatment indication

• single root canal

Exclusion Criteria:

• previously treated tooth

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrotic Pulp
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis
• Pulpitis

Intervention

Procedure:
• ProTaper Next
Root canal instrument
• TF Adaptive
Root canal instrument

Locations

Country	Name	City	State
Turkey	Bülent Ecevit University, Faculty of Dentistry	Zonguldak

Sponsors (1)

Lead Sponsor	Collaborator
Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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