Clinical trial NCT06005545: A Study to Compare Various Root Canal Cleaning Devices Based on Cavitation,Ultrasonic and Conventional Methods.
Official 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apical Periodontitis
Keywords: Root Canal Treatment
Endodontic Treatment
Root Canal Debridement
Lead sponsor: Lumendo AG
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.

Arm 1: Passive ultrasonic irrigation group (PUI); shaping up to WL with 25.06, 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) Arm 3: Conventional group; shaping up to WL of 25.06, irrigation protocol with NaOCl (sodium hypochlorite)
Primary purpose: TREATMENT

Brief 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.

Detailed 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:

1. 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.
2. 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.

Eligibility 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.

Primary outcomes:
measure: Primary effectiveness endpoint
timeFrame: 12 months
Secondary outcomes:
measure: Safety endpoint
timeFrame: 1 month
measure: Secondary effectiveness endpoints
timeFrame: 24 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics
state: Unkapanı, Fatih
Study officials:
References: