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Clinical Trials/NCT04510571
NCT04510571
Completed
Not Applicable

Evaluation of Postoperative Pain and Instrumentation Time After Root Canal Treatment With Rotary and Reciprocal File Systems in Children - A Randomized Clinical Trial

Ege University1 site in 1 country50 target enrollmentJuly 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Ege University
Enrollment
50
Locations
1
Primary Endpoint
Postoperative Pain Assessment After 24 hours
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Postoperative pain is a common symptom of a flare up after root canal treatments (RCTs). Insufficient instrumentation, extrusion of irrigation solutions and debris and existence of a periapical lesion are the factors affecting postoperative pain after root canal treatments. Aim of this study is to evaluate the postoperative pain and instrumentation time of single-file reciprocating system and multiple-file Ni-Ti rotary system in children ages between 9-12. Study was conducted on fifty first permanent mandibular molars with the diagnosis of irreversible pulpitis. Patients were randomly separated into two groups and RCTs were completed with either Reciproc Blue or Protaper Next file systems. Instrumentation time for each system was noted and patients were given a pain scale which included visual analog scale for 6, 24, 48 and 72 hours after treatment. Postoperative pain scores and instrumentation times were analyzed statistically with chi square test and student t test. There was no statistically significant difference in postoperative pain between Reciproc Blue and Protaper Next systems at all time intervals. Instrumentation time was significantly shorter in the Reciproc Blue group in comparison with the Protaper Next group. In conclusion, shorter treatment time of single-file reciprocating systems may be more patient friendly and comfortable than multiple-file rotary systems in RCTs among children.

Registry
clinicaltrials.gov
Start Date
July 10, 2020
End Date
July 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alp Abidin Ateşçi

Principal Investigator

Ege University

Eligibility Criteria

Inclusion Criteria

  • Patients with first permanent mandibular molar teeth which had been diagnosed with symptomatic irreversible pulpitis with no periapical pathology or abscess were included in the study.

Exclusion Criteria

  • Patients who were on antibiotics or analgesics preoperatively were not included in the study.

Outcomes

Primary Outcomes

Postoperative Pain Assessment After 24 hours

Time Frame: 24 hours after treatment

Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).

Postoperative Pain Assessment After 72 hours

Time Frame: 72 hours after treatment

Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).

Postoperative Pain Assessment After 6 hours

Time Frame: 6 hours after treatment

Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).

Postoperative Pain Assessment After 48 hours

Time Frame: 48 hours after treatment

Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).

Secondary Outcomes

  • Instrumentation Time(During procedure)

Study Sites (1)

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