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A Study to Compare Various Root Canal Cleaning Devices Based on Cavitation,Ultrasonic and Conventional Methods.

NCT06005545 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2023-12-06

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the effectiveness of various root canal cleaning devices based on the principle of cavitation, ultrasonics, and conventional methods in a normal healthy adult population aged between 18 to 75 years requiring root canal treatment.

The main question\[s\] it aims to answer are:

* Effectiveness of the cleaning mechanism
* Evaluate the safety of use of the device. Participants will be provided root canal treatment. Participants will be asked to record their post-operative pain levels in a Patient Pain diary. The healing rate of the lesion will be examined at follow-up visits using intraoral X-rays. At the end of the study, a statistical analysis of the clinical outcomes of the root canal treatment will be examined and evaluated in every group.

Conditions

  • Apical Periodontitis

Interventions

DEVICE

Passive Ultrasonic Irrigation (PUI) group

Passive ultrasonic irrigation is the current golden standard in root canal cleaning and irrigation devices. It is used after root canal shaping using manual or rotary instruments. It uses sodium hypochlorite which is mobilized in the canal using ultrasonic non-cutting tips to clean, debride, disinfect, and prepare the root canal for obturation.

DEVICE

Endoclean (EC) group

Endoclean is a novel device that uses hydraulic inertial cavitation with the help of pressure and saline solution to debride the root canal after minimal shaping using manual or rotary shaping instruments. It is used to effectively clean, debride and prepare the root canal before obturation in the root canal treatment procedure.

DEVICE

Conventional group

Conventional root canal preparation uses manual or rotary files along with manual irrigation using syringes and irrigant solutions like sodium hypochlorite or EDTA to clean, debride and prepare the root canal for obturation.

Sponsors & Collaborators

  • Lumendo AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-04
Primary Completion
2025-03-31
Completion
2026-03-31

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 NCT06005545 on ClinicalTrials.gov