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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04990115
Enrollment
50
Registered
2021-08-04
Start date
2020-08-01
Completion date
2021-03-01
Last updated
2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Root Canal Infection

Keywords

Reciprocation, Kinematics, Bacterial reduction, post-operative pain, endodontic flare-ups

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.

Interventions

OTHERroot canal shaping

root canal treatment

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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

Intervention model description

The trial design is a prospective, parallel, randomized with an allocation ratio (1:1), double-blinded, single-center clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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 * swelling * intake of antibiotics within previous 3 months * pain with percussion

Design outcomes

Primary

MeasureTime frameDescription
bacterial reductionup to 1 hourpre-instrumentation and post-instrumentation bacterial cultures to detect change in bacterial count after root canal instrumentation with the different kinematics
post operative painafter the treatment visit by 24 hoursVisual analogue scale from 0-100 where 0 is the lowest and 100 is the highest

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026