Evaluation of Postoperative Pain in Children

Not Applicable

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT04510571
• Lead Sponsor: Ege University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-10
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Study First Posted: 2020-08-12
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Assessment After 24 hours	24 hours after treatment	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	72 hours after treatment	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 6 hours	6 hours after treatment	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	48 hours after treatment	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

Name	Time	Method
Instrumentation Time	During procedure	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.

Trial Locations

Locations (1)

Ege University; 🇹🇷 Izmir, Turkey