Evaluation of Postoperative Pain in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: Evaluating Postoperative Pain After Root Canal Treatment with Protaper Next; Other: Evaluating Postoperative Pain After Root Canal Treatment with Reciproc Blue Files

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35100
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Protaper Next; Protaper Next group (n=25): The instrumentation of mesial and distal canals were done according to manufacturer's recommendations using X1 and X2 (25.06) at a rotational speed of 300 rpm. Then X3 and X4 (40.06) instruments were used to enlarge distal canals in order to compare the results with the Reciproc Blue group. The root canals were irrigated with 2 ml of %2,5 sodium hypochlorite after each instrument exchange.	Other: Evaluating Postoperative Pain After Root Canal Treatment with Protaper Next; Patients were randomly separated into two groups and root canal treatments were completed with 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.; Other Names: Root Canal Instrumentation; Root Canal Treatment; Assessing Postoperative Pain; Instrumentation Time
Active Comparator: Reciproc Blue; Reciproc Blue group (n=25) : The canals were shaped with in accordance with the manufacturer's recommendations. R25 (25.08) instrument was introduced into the canal with slow pecking movement within a 3 mm range each time. The flutes and remnants were cleaned after 3 pecking moves. Then R40 instrument (40.06) was selected to shape the distal canals as the #20 K file was passively introduced to the working length. The root canals were irrigated with 2 ml of %2,5 sodium hypochlorite after each instrument exchange.	Other: Evaluating Postoperative Pain After Root Canal Treatment with Reciproc Blue Files; Patients were randomly separated into two groups and root canal treatments were completed with Reciproc Blue 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.; Other Names: Root Canal Instrumentation; Root Canal Treatment; Assessing Postoperative Pain; Instrumentation Time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Assessment After 6 hours	Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).	6 hours after treatment
Postoperative Pain Assessment After 24 hours	Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).	24 hours after treatment
Postoperative Pain Assessment After 48 hours	Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).	48 hours after treatment
Postoperative Pain Assessment After 72 hours	Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).	72 hours after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instrumentation Time	The time for root canal instrumentation was recorded after working length determination until the end of instrumentation including irrigation between file changes within the sequence.	During procedure

Collaborators and Investigators

• Sponsor: Ege University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: postoperative pain; root canal treatment; reciprocal motion; rotary motion
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 20-7T/55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No