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Clinical Trials/NCT04990115
NCT04990115CompletedNot Applicable

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

Ain Shams University1 site in 1 country50 target enrollmentStarted: August 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
post operative pain

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Sequentially generated numbers were placed in opaque envelopes until the intervention was conducted and each participant was asked to select an envelope that determine which group of intervention was assumed

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

rotation

Active Comparator

root canal preparation performed using rotating instruments

Intervention: root canal shaping (Other)

reciprocation

Active Comparator

root canal preparation performed using reciprocating instruments

Intervention: root canal shaping (Other)

Outcomes

Primary Outcomes

post operative pain

Time Frame: after the treatment visit by 72 hours

Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest

bacterial reduction

Time Frame: up to 1 hour

pre-instrumentation and post-instrumentation bacterial cultures to detect change in bacterial count after root canal instrumentation with the different kinematics

post operative pain

Time Frame: after the treatment visit by 24 hours

Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest

post operative pain

Time Frame: after the treatment visit by 48 hours

Visual analogue scale from 0-100 where 0 is the lowest and 100 is the highest

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shehab El Din Mohamed Saber

professor

Ain Shams University

Study Sites (1)

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