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

Lumendo

Status

Enrolling

Conditions

Apical Periodontitis

Treatments

Device: Passive Ultrasonic Irrigation (PUI) group

Device: Conventional group

Device: Endoclean (EC) group

Study type

Interventional

Funder types

Industry

Identifiers

NCT06005545

EC_5301_V1.0_CIP

Details and patient eligibility

About

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.

Full description

Study title: "A Comparative Evaluation of Effectiveness in Root Canal Debridement using Inertial Cavitation Device vs Passive Ultrasonic Irrigation and Conventional Preparation: A Randomized Controlled Clinical Trial".

Study Design: This is a prospective, 3-arm randomized, non-blinded, single-center pivotal clinical investigation, performed to evaluate the effectiveness and safety of the Endoclean device with 2 comparator arms.

Primary objective: To test the effectiveness of the Endoclean device for root canal debridement up to 12-month follow-up.

Secondary objective: To test the extended effectiveness and safety of the Endoclean device up to a 24-month follow-up.

Inclusion/Exclusion Criteria:

Inclusion Criteria

•Patients aged between 18-75 years with ASA (American Society of Anesthesiologists) classification 1 and 2.

ASA 1: A normal healthy patient. Example: Fit, non-obese BMI (Body mass index) under 30, a non-smoking patient with good exercise tolerance.

ASA 2: A patient with mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI under 35, frequent social drinker, or cigarette smoker).
- Patients who agreed to participate and who have signed the informed consent.
- Patients presenting with symptomatic and/or asymptomatic apical periodontitis and radiographic evidence of apical periodontitis in anterior or posterior teeth larger than 1.5 mm in diameter.
- Mature tooth with closed apices
- Tooth that has never been treated with root canal therapy.
Exclusion Criteria:
- Patients, who have pre-existing health or oral conditions that placed them at risk during the trial.
- Patients with generalized untreated periodontal disease.
- Patients with a history of analgesic intake within the past 3 days or antibiotics in the last 1 month.
- Uncooperative patients
- Teeth with immature apices, root resorption, or requiring extensive prosthetic rehabilitation.
- Teeth that cannot be made functional nor restored or difficult to access teeth with no importance (wisdom teeth)
- Teeth with insufficient periodontal support
- Teeth with poor prognosis, for example due to deep root caries, large root resorption or open apex cases
- Fractured teeth
- Local anatomical factors such as an inaccessible root end
- Presence of fractured instrument in the root canal
- Pregnant women
- Patients unable to understand the study procedure.

Number of Participants:

Total number of participants = 109 subjects Arm 1: 40 subjects Arm 2: 40 subjects Arm 3: 29 subjects Test device: Endoclean (Lumendo AG): hydraulic cavitation cleaning device Control device 1: Passive ultrasonic irrigation (PUI) Control device 2: Rotary files with standard NaOCl irrigation Study duration: 2-3 years The results of the Endoclean group shall be compared to data gathered from the comparator device groups and results shall be presented in the clinical investigation report.

Enrollment

109 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

•Patients aged between 18-75 years with ASA (American Society of Anesthesiologists) classification 1 and 2.

ASA 1: A normal healthy patient. Example: Fit, non-obese BMI (Body mass index) under 30, a non-smoking patient with good exercise tolerance.

ASA 2: A patient with mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI under 35, frequent social drinker, or cigarette smoker).

Patients who agreed to participate and who have signed the informed consent.
Patients presenting with symptomatic and/or asymptomatic apical periodontitis and radiographic evidence of apical periodontitis in anterior or posterior teeth larger than 1.5 mm in diameter.
Mature tooth with closed apices
Tooth that has never been treated with root canal therapy.

Exclusion criteria

Patients, who have pre-existing health or oral conditions that placed them at risk during the trial.
Patients with generalized untreated periodontal disease.
Patients with a history of analgesic intake within the past 3 days or antibiotics in the last 1 month.
Uncooperative patients
Teeth with immature apices, root resorption, or requiring extensive prosthetic rehabilitation.
Teeth that cannot be made functional nor restored or difficult to access teeth with no importance (wisdom teeth)
Teeth with insufficient periodontal support
Teeth with poor prognosis, for example due to deep root caries, large root resorption or open apex cases
Fractured teeth
Local anatomical factors such as an inaccessible root end.
Presence of fractured instrument in the root canal
Pregnant women
Patients unable to understand the study procedure.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

109 participants in 3 patient groups

Passive Ultrasonic Irrigation group (PUI)

Active Comparator group

Description:

Arm 1: Passive ultrasonic irrigation group (PUI); shaping up to WL with 25.06,

Treatment:

Device: Passive Ultrasonic Irrigation (PUI) group

Endoclean group (EC)

Experimental group

Description:

Arm 2: Endoclean (EC) group; shaping up to WL with 20.06; EC application tip kept 3mm short of WL, irrigation protocol with NaOCl (sodium hypochlorite)

Treatment:

Device: Endoclean (EC) group

Conventional Group

Active Comparator group

Description:

Arm 3: Conventional group; shaping up to WL of 25.06, irrigation protocol with NaOCl (sodium hypochlorite)

Treatment:

Device: Conventional group