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Evaluation of Postoperative Pain in Children

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Evaluating Postoperative Pain After Root Canal Treatment with Protaper Next
Evaluating Postoperative Pain After Root Canal Treatment with Reciproc Blue Files
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Postoperative Pain focused on measuring postoperative pain, root canal treatment, reciprocal motion, rotary motion

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Protaper Next

Reciproc Blue

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
August 10, 2020
Last Updated
August 11, 2020
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04510571
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative pain, root canal treatment, reciprocal motion, rotary motion

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protaper Next
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Reciproc Blue
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Evaluating Postoperative Pain After Root Canal Treatment with Protaper Next
Other Intervention Name(s)
Root Canal Instrumentation, Root Canal Treatment, Assessing Postoperative Pain, Instrumentation Time
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Evaluating Postoperative Pain After Root Canal Treatment with Reciproc Blue Files
Other Intervention Name(s)
Root Canal Instrumentation, Root Canal Treatment, Assessing Postoperative Pain, Instrumentation Time
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative Pain Assessment After 6 hours
Description
Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).
Time Frame
6 hours after treatment
Title
Postoperative Pain Assessment After 24 hours
Description
Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).
Time Frame
24 hours after treatment
Title
Postoperative Pain Assessment After 48 hours
Description
Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).
Time Frame
48 hours after treatment
Title
Postoperative Pain Assessment After 72 hours
Description
Postoperative pain scores were scored using Modified Wong Baker pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).
Time Frame
72 hours after treatment
Secondary Outcome Measure Information:
Title
Instrumentation Time
Description
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.
Time Frame
During procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Ege University
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17956561
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.
Results Reference
result
PubMed Identifier
28198972
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.
Results Reference
result
PubMed Identifier
27041109
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.
Results Reference
result

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Evaluation of Postoperative Pain in Children

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