Endodontic Treatment Clinical Trial
Official title:
A Prospective, Single-arm, Non-randomized Controlled Trial to Test the Effectiveness, Safety and Performance of a Novel Dental Obturation Material
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 answers is 1. To test the effectiveness of the Endofill device for root canal obturation up to 12-month follow-up period. 2. To test the performance of the Endofill device evaluated with periapical radiographs immediately on completion of procedure. The participants requiring root canal treatment will be treated with obturated using Endofill material and post-treatment follow-up vistis will be conducted for 1 year. This is a single-arm study with no comparison groups.
Status | Not yet recruiting |
Enrollment | 63 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Medipol University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Lumendo AG | Avania |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of root canal treatment using Endofill | To measure effectiveness by assessing overall healing, through rate of reduction in apical periodontitis, from baseline up to 12 months post-procedure by measuring periapical radiolucency size. | 12 months | |
Secondary | Safety of root canal treatment using endofill | To measure safety by measuring postoperative pain from completion of the procedure up to 1 month of follow-up period (24 hours, 48 hours, 72 hours, 7 days, and 1 month). Pain is measured by VAS assessment. It consists of a line, approximately 10 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain with a frowning face image. A patient is asked to indicate his/her perceived pain intensity along a 100 mm horizontal line, and this rating is then measured from the left edge. A VAS score of 0 indicates no pain and a score of 10 indicates the highest level of pain experienced. | 1 month |
Status | Clinical Trial | Phase | |
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