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Completed

NCT Number: NCT04990115

Bacterial Reduction and Post Operative Endodontic-pain Using 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

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Key information

Conditions

Root Canal Infection Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry. Ain Shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

root canal shaping

Other

root canal treatment

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Aug 4, 2021
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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