Apical PeriodontitisNCT06005545
A Study to Compare Various Root Canal Cleaning Devices Based on Cavitation,Ultrasonic and Conventional Methods.
A study testing Passive Ultrasonic Irrigation (PUI) group, Endoclean (EC) group and Conventional group in people with Apical Periodontitis, run by Lumendo AG at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Passive Ultrasonic Irrigation (PUI) group, Endoclean (EC) group and Conventional group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2023to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- •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.
Who cannot join
- 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)
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics
Istanbul, Unkapanı, Fatih, 34083
Tan Firat EYÜBOĞLU, DDS, PhD, +90 530 463 6059, tfeyuboglu@yahoo.com
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Apical Periodontitis
- Being tested
- Passive Ultrasonic Irrigation (PUI) group, Endoclean (EC) group, Conventional group
- Keywords
- Root Canal Treatment, Endodontic Treatment, Root Canal Debridement
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Ultrasonic Irrigation (PUI) groupDevice
Also called Ultrasonic 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.
Endoclean (EC) groupDevice
Also called Cavitation 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.
Conventional groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Passive Ultrasonic Irrigation group (PUI) | Active comparator | Arm 1: Passive ultrasonic irrigation group (PUI); shaping up to WL with 25.06, Receives: 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) Receives: 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) Receives: Device: Conventional group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- The patient had no discomfort in treated tooth
- The patient had no percussive pain during the examination in treated tooth
Measured: 12 months
Secondary outcomes (2)
Safety endpoint
Freedom from postoperative pain up to 7 days of follow-up period (24 hours, 48 hours, 72 hours, 7 days and 1 month). Pain is measured by Visual Analogue Scale (VAS) assessment.The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image. The VAS is used to assist individuals to determine pain levels, who may not be accustomed to rating their pain on other types of scales, such as a numeric rating scale.
Measured: 1 month
Secondary effectiveness endpoints
Successful healing of periapical lesion up to 24 months post-procedure. Long-term effectiveness success shall be defined as a continued reduction or complete absence of periapical lesion radiolucency at 24m FU since the procedure with no clinical symptoms (i.e no discomfort in treated tooth and no percussive pain during examination)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start4 Oct 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumendo AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005545
- Sponsor's protocol ID
- EC_5301_V1.0_CIP
- Status last verified
- Dec 2023
- First submitted
- 8 Aug 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06005545
- Acronym / sponsor ID
- EC_5301_V1.0_CIP
- Conditions
- Apical Periodontitis
- Keywords
- Root Canal Treatment, Endodontic Treatment, Root Canal Debridement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Lumendo AGIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Passive Ultrasonic Irrigation group (PUI) | Active comparator | Device: Passive Ultrasonic Irrigation (PUI) groupArm 1: Passive ultrasonic irrigation group (PUI); shaping up to WL with 25.06, |
| Endoclean group (EC) | Experimental | Device: Endoclean (EC) groupArm 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) |
| Conventional Group | Active comparator | Device: Conventional groupArm 3: Conventional group; shaping up to WL of 25.06, irrigation protocol with NaOCl (sodium hypochlorite) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- •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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive Ultrasonic Irrigation (PUI) groupAlso: Ultrasonic groupPassive 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 | Passive Ultrasonic Irrigation group (PUI) |
| Endoclean (EC) groupAlso: Cavitation groupEndoclean 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 | Endoclean group (EC) |
| Conventional groupConventional 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. | Device | Conventional Group |
Primary outcome
Primary effectiveness endpoint
Time frame: 12 months
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
2 secondary outcomes
Safety endpoint
Time frame: 1 month
Secondary effectiveness endpoints
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Ultrasonic Irrigation (PUI) group, Endoclean (EC) group and Conventional group in people with Apical Periodontitis, run by Lumendo AG at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tan Fırat Eyüboglu Assoc. Prof. (+90 530 463 60 59, tfeyuboglu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary effectiveness endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.