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

NCT06005545 | Recruiting

• 1 other identifier: EC_5301_V1.0_CIP
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Apical Periodontitis

Keywords

Root Canal Treatment; Endodontic Treatment; Root Canal Debridement

Outcome Measures

Primary Outcomes (1)

• Primary effectiveness endpoint

  Successful healing of periapical lesion up to 12 months post-procedure where success is defined as completely healed or healing lesion with absence of clinical symptoms. Healing is assessed by measuring the reduction in periapical lesion radiolucency, up to 12 months post-procedure, using the PAI (periapical index score). The absence of clinical symptoms is defined as: 1. The patient had no discomfort in treated tooth 2. The patient had no percussive pain during the examination in treated tooth

  12 months

Secondary Outcomes (2)

• Safety endpoint

  1 month

• Secondary effectiveness endpoints

  24 months

Study Arms (3)

Passive Ultrasonic Irrigation group (PUI)

ACTIVE COMPARATOR

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

Device: Passive Ultrasonic Irrigation (PUI) group

Endoclean group (EC)

EXPERIMENTAL

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)

Device: Endoclean (EC) group

Conventional Group

ACTIVE COMPARATOR

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

Device: Conventional group

Interventions

Passive Ultrasonic Irrigation (PUI) group DEVICE

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.

Also known as: Ultrasonic group

Passive Ultrasonic Irrigation group (PUI)

Endoclean (EC) group DEVICE

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.

Also known as: Cavitation group

Endoclean group (EC)

Conventional group DEVICE

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.

Conventional Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lumendo AG: lead

Study Sites (1)

İstanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics

Istanbul, Unkapanı, Fatih, 34083, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Central Study Contacts

Tan Fırat Eyüboglu Assoc. Prof.

CONTACT

+90 530 463 60 59; tfeyuboglu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 22, 2023
• Study Start: October 4, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)