Post-operative Pain With Different Apical Finishing Sizes After Single Visit Root Canal Treatment

Comparative Evaluation of Post-operative Pain With Different Apical Finishing Sizes After Single Visit Root Canal Treatment

This is a randomized controlled parallel clinical, prospective split mouth, triple blinded study. Sample size calculation was conducted and it was 25 subjects per group for a total of 50 sides to compensate for drop-outs.

Patient selection and preparation:

All root canal treatments were performed by a single endodontic consultant. All subjects were selected from walk in patients presented to the endodontic clinic of the British university in Egypt. Cases that met the inclusion criteria where selected for this study. All patients were verbally informed about the procedure's benefits and that the results of the treatment will be used to this study and the risks of the procedure was explicitly explained to them. After the verbal consent patients were handed a written form consent to sign upon.

All data of post-operative pain were recorded by a second blinded clinician through a visual analog scale (VAS). Post-operative monitoring periods will be recorded in 12 hours, 24 hours, 3 days and one week Data was sent to the statistician with group names only to fulfill the triple blinding criteria and results will be interpreted

Study Overview

• Status: Completed
• Conditions: Pain Assessment
• Intervention / Treatment: Behavioral: Pain assessment

Detailed Description

This is a randomized controlled parallel clinical, prospective split mouth, triple blinded study. Sample size calculation was conducted using G*Power 3.1.9.4 software based on data obtained from a previous study ] It was estimated that a minimum sample size of 19 subjects (sides) per group for a total of 38 sides would be essential for an effect size of 0.97 with an alpha error of 0.05 and a power beta of 0.90 to achieve 95% confidence of a true difference between the groups. Sample size was increased by 25% to 25 subjects per group for a total of 50 sides to compensate for drop-outs.

Patient selection and preparation:

All root canal treatments were performed by a single endodontic consultant. All subjects were selected from walk in patients presented to the endodontic clinic of the British university in Egypt. Cases that were diagnosed and did not meet the inclusion criteria were referred to the intern clinic for dental care. Cases that met the inclusion criteria where selected for this study. All patients were verbally informed about the procedure's benefits and that the results of the treatment will be used to this study and the risks of the procedure was explicitly explained to them. After the verbal consent patients were handed a written form consent to sign upon.

Procedure:

Radiographs were taken by a Paralleled long cone periapical radiography. To ensure a visible root canal ≤30° of canal curvature and a periapical index (PAI score) of 3-5 in addition of initial confirmation of root canal types. All patients were anesthetized, rubber dam applied, and access cavities were performed. After root canal exploration and scouting, root canal systems were reconfirmed to be the types selected for this study.

Initial binding file was selected for all root canals to ensure it met the inclusion size of mesial roots #20 and distal #30. After patency and glide path were performed by K-files up to size #20, engine driven canal enlargement was applied using E3 Azure files to final finishing size according to the grouping.

Group A: (left side of the patient) were prepared 2 sizes larger than the IBF, to size 35#/.04 mesial canals and 40#/.04 distal canals.

Group B: (right side of the patient) were prepared 3 sizes larger than the IBF, to size 40#/.04 mesial canals and 45#/.04 distal canals.

All data of post-operative pain were recorded by a second blinded clinician through a visual analog scale (VAS). Post-operative monitoring periods will be recorded in 12 hours, 24 hours, 3 days and 1 week.

Data was sent to the statistician with group names only to fulfill the triple blinding criteria and results will be interpreted

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Egypt
  • El Shrouk
    • Cairo, El Shrouk, Egypt
      • British university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All types of adult population

Description

Inclusion Criteria:

• Age: 20-50
• Gender: Males and Females, random selection.
• Systemic status: healthy patients (Category: American Society of Anaesthesiologists class 1)
• Bilateral exposed mandibular first or second permanent molars
• Molars should have separate mesial and distal roots
• Mesial roots confirmed to be type three root canal system
• Distal root confirmed to be type one root canal system
• Normal periapical radiograph and no bone changes
• Symptomatic irreversible pulpitis
• I.B.F. in mesial roots not more than #20, and distal root not more than #30

Exclusion Criteria:

• Type two root canal system in mesial roots
• Type two or three root canal systems in distal roots
• Signs of apical involvement in the radiograph
• Any systemic conditions altering the treatment or requiring medications or precautions

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A: (left side of the patient; prepared 2 sizes larger than the IBF, to size 35#/.04 mesial canals and 40#/.04 distal canals.	Behavioral: Pain assessment; Pain was assesd postoperatively in both groups at time intervals
Group B (right side of the patient; prepared 3 sizes larger than the IBF, to size 40#/.04 mesial canals and 45#/.04 distal canals.	Behavioral: Pain assessment; Pain was assesd postoperatively in both groups at time intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment at 12 hours	post-operative pain will be recorded by a second blinded clinician using a visual analog scale where patient grades his level of pain from minimum to maximum Post-operative monitoring periods wiere recorded	12 hours
Pain assessment at 24 hours	Comparative post-operative pain will be recorded by a second blinded clinician using a visual analog scale where patient grades his level of pain from minimum to maximum Post-operative monitoring periods wiere recorded	24 hours
Pain assessment at 3 days	post-operative pain will be recorded by a second blinded clinician using a visual analog scale where patient grades his level of pain from minimum to maximum Post-operative monitoring periods wiere recorded	3days
Pain assessment at 1 week	post-operative pain will be recorded by a second blinded clinician using a visual analog scale where patient grades his level of pain from minimum to maximum Post-operative monitoring periods wiere recorded	1 week

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: FD-BUE-REC 23-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No