Clinical trial NCT04510571: Evaluation of Postoperative Pain in Children
Official title: Evaluation of Postoperative Pain and Instrumentation Time After Root Canal Treatment With Rotary and Reciprocal File Systems in Children - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative pain
root canal treatment
reciprocal motion
rotary motion
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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.

Primary outcomes:
measure: Postoperative Pain Assessment After 6 hours
timeFrame: 6 hours after treatment
measure: Postoperative Pain Assessment After 24 hours
timeFrame: 24 hours after treatment
measure: Postoperative Pain Assessment After 48 hours
timeFrame: 48 hours after treatment
measure: Postoperative Pain Assessment After 72 hours
timeFrame: 72 hours after treatment
Secondary outcomes:
measure: Instrumentation Time
timeFrame: During procedure
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
Study officials:
References:
citation: Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.
citation: Cicek E, Kocak MM, Kocak S, Saglam BC, Turker SA. Postoperative pain intensity after using different instrumentation techniques: a randomized clinical study. J Appl Oral Sci. 2017 Jan-Feb;25(1):20-26. doi: 10.1590/1678-77572016-0138.
citation: Shokraneh A, Ajami M, Farhadi N, Hosseini M, Rohani B. Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial. Clin Oral Investig. 2017 Jan;21(1):413-418. doi: 10.1007/s00784-016-1807-2. Epub 2016 Apr 4.