A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material.

Launched by LUMENDO AG · Mar 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new dental material called Endofill that is used during root canal treatments. The main goal is to see how effective, safe, and reliable this material is over a 12-month period after the treatment. Participants in the study will receive a root canal using the Endofill material and will have follow-up visits to check on their progress. This study is not comparing Endofill to any other treatments, but it aims to gather important information about its performance through X-rays taken immediately after the procedure.

To participate in this trial, individuals must be between 18 and 75 years old and generally healthy or have mild health issues. Eligible participants should have specific dental problems, such as infections at the root of their teeth, and their teeth must be mature and never treated before with a root canal. Those with certain health conditions, severe gum disease, or who have taken painkillers or antibiotics recently cannot join the study. Participants will be closely monitored for a year, allowing researchers to learn more about how well the Endofill material works in treating root canal issues.

Gender

ALL

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.