Status:
RECRUITING
A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material.
Lead Sponsor:
Lumendo AG
Collaborating Sponsors:
Avania
Conditions:
Endodontic Treatment
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this study is prospective, single-arm, non-randomized controlled trial to test the effectiveness, safety and performance of a novel dental obturation material. The main question sit answer...
Detailed Description
Study Title: "A prospective, single-arm, non-randomized controlled trial to test the effectiveness, safety and performance of a novel dental obturation material." Protocol Version and Date: Version ...
Eligibility Criteria
Inclusion Criteria:
• Patients aged 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 root canal treatment, 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.
Key Trial Info
Start Date :
June 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06312085
Start Date
June 7 2024
End Date
December 1 2026
Last Update
July 12 2024
Active Locations (1)
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1
Medipol University
Istanbul, Turkey (Türkiye)