Evaluation of Postoperative Pain in Children

Study Overview
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Other: Evaluating Postoperative Pain After Root Canal Treatment with Protaper Next
* Other: Evaluating Postoperative Pain After Root Canal Treatment with Reciproc Blue Files


Participation Criteria
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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. Exclusion Criteria: Patients who were on antibiotics or analgesics preoperatively were not included in the study.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Protaper Next<br>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<br>* 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.<br>* Other names: Instrumentation Time;|
| Active Comparator: Reciproc Blue<br>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<br>* 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.<br>* Other names: Instrumentation Time;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, root canal treatment, reciprocal motion, rotary motion