Actively Recruiting
A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material.
Led by Lumendo AG · Updated on 2024-07-12
63
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
Sponsors
L
Lumendo AG
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18-75 years with ASA classification 1 or 2
- Patients who agreed to participate and have signed informed consent
- Patients presenting with symptomatic or asymptomatic apical periodontitis with radiographic lesion over 1.5 mm
- Mature tooth with closed apex
- Tooth that has never been treated with root canal therapy
You will not qualify if you...
- Patients with pre-existing health or oral conditions that place them at risk during the trial
- Patients with generalized untreated periodontal disease
- Patients who have taken analgesics within past 3 days or antibiotics within last 1 month
- Uncooperative patients
- Teeth with immature apices, root resorption, or needing extensive prosthetic rehabilitation
- Teeth that cannot be restored or are difficult to access (e.g., wisdom teeth)
- Teeth with insufficient periodontal support
- Teeth with poor prognosis for root canal treatment (deep root caries, large root resorption, open apex cases)
- Fractured teeth
- Local anatomical factors making root end inaccessible
- Presence of fractured instrument in the root canal
- Pregnant women
- Patients unable to understand the study procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medipol University
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
A
Anupama Tripathi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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