Bacterial Reduction and Post Operative Endodontic-pain Using Different Kinematics

Root Canal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04990115
• Other study ID #: FDASU-RECD091615
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: September 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Root Canal Infection

Intervention

Other:
• root canal shaping
root canal treatment

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry. Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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