Bacterial Reduction and Post Operative Endodontic-pain Using Different Kinematics

NCT ID: NCT04990115

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-03-01

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.

Conditions

Root Canal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

rotation

root canal preparation performed using rotating instruments

Group Type: ACTIVE_COMPARATOR

root canal shaping

Intervention Type: OTHER

root canal treatment

reciprocation

root canal preparation performed using reciprocating instruments

Group Type: ACTIVE_COMPARATOR

root canal shaping

Intervention Type: OTHER

root canal treatment

Interventions

root canal shaping

root canal treatment

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Shehab El Din Mohamed Saber

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

shehabeldin M Saber, phd

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

Faculty of Dentistry. Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FDASU-RECD091615

Identifier Type: -

Identifier Source: org_study_id