Bacterial Reduction and Post Operative Endodontic-pain Using Different Kinematics

Bacterial Reduction and Post Operative Pain After Cleaning and Shaping of Root Canals With Single File Systems Used in Different Kinematics

This study was conducted to compare the antibacterial effect and degree of postoperative pain of single rotary and reciprocating file systems during endodontic therapy

Study Overview

• Status: Completed
• Conditions: Root Canal Infection
• Intervention / Treatment: Other: root canal shaping

Detailed Description

Introduction: Instrumentation kinematic is one of the many aspects of shaping files that underwent heavy development through the last decade. The impact of the type of motion used to drive shaping instruments was heavily studied but mostly in-vitro. More randomized clinical trials are needed to achieve a reliable body of data concerning the issue.

Aim: This study aimed to evaluate the effect of varying shaping files' kinematics on bacterial reduction, post-operative pain and the incidence of flare-ups. Methods: Necrotic, asymptomatic, single-rooted mandibular premolars with single canals were used in the study, where 46 patients were randomly allocated to two groups. In the first group, WaveOne Gold was used for mechanical preparation while One Shape was used in the second group. Samples were taken preoperatively (S1) and after chemomechanical preparation (S2). Bacterial reduction was evaluated and compared between both groups via culturing technique and quantitative analysis by real-time polymerase chain reaction (qPCR). Post-operative pain and the incidence of flare-ups were also evaluated using the visual analog scale (VAS) method.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • faculty of Dentistry. Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• mandibular premolars
• single rooted
• single canalled
• necrotic pulps
• asymptomatic apical periodontitis

Exclusion Criteria:

• gross caries
• root/crown fracture
• sinus tract
• swelling
• intake of antibiotics within previous 3 months
• pain with percussion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: rotation; root canal preparation performed using rotating instruments	Other: root canal shaping; root canal treatment
Active Comparator: reciprocation; root canal preparation performed using reciprocating instruments	Other: root canal shaping; root canal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bacterial reduction	pre-instrumentation and post-instrumentation bacterial cultures to detect change in bacterial count after root canal instrumentation with the different kinematics	up to 1 hour
post operative pain	Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest	after the treatment visit by 24 hours
post operative pain	Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest	after the treatment visit by 48 hours
post operative pain	Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest	after the treatment visit by 72 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: shehabeldin M Saber, phd, Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: June 26, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Kinematics; post-operative pain; Reciprocation; Bacterial reduction; endodontic flare-ups
• Other Study ID Numbers: FDASU-RECD091615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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