Evaluation of Postoperative Pain in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-10

Study Completion Date

2020-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Evaluating Postoperative Pain After Root Canal Treatment with Protaper Next

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Evaluating Postoperative Pain After Root Canal Treatment with Reciproc Blue Files

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Root Canal Instrumentation Root Canal Treatment Assessing Postoperative Pain Instrumentation Time Root Canal Instrumentation Root Canal Treatment Assessing Postoperative Pain Instrumentation Time

Eligibility Criteria

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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.