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A First in Human Study to Compare Feasibility of Inertial Cavitation Irrigation to SNI in Root Canal Treatment.

NCT05374434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-07-25

Study results available
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Summary

The study design is a single-center 2-arm randomized controlled clinical trial. 10 subjects (teeth) requiring a root canal treatment will be enrolled in 2 groups (5 in each group). The aim of the study is to compare the postoperative pain intensity levels in patients with asymptomatic teeth diagnosed for non-surgical orthograde root canal treatment that are disinfected during the root canal treatment procedure by manual irrigation with sodium hypochlorite (NaOCl) solution using an endodontic needle or by a inertial cavitation-generating device.

Conditions

  • Root Canal Treatment
  • Post Operative Pain

Interventions

OTHER

Conventional irrigation

The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.

DEVICE

Inertial cavitation

The participant will be treated by inertial cavitation-generating device, that generates hydraulic cavitation to clean root canals deeper and more effectively than other existing systems.

Sponsors & Collaborators

  • Lumendo AG

    lead INDUSTRY

Principal Investigators

  • Tan Firat EYÜBOĞLU, DDS, MDS · İstanbul Medipol University, Department of Endodontics, İstanbul/Türkiye

  • Mutlu ÖZCAN, DDS, MDS · İstanbul Medipol University, Istanbul Turkey

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-10
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05374434 on ClinicalTrials.gov