Clinical Efficacy of AH Plus Bioceramic Sealer (NCT05763420) | Clinical Trial Compass
By InvitationNot Applicable
Clinical Efficacy of AH Plus Bioceramic Sealer
Kuwait136 participantsStarted 2023-08-07
Plain-language summary
The goal of this clinical trial is to assess the efficacy and outcome of sealer-based obturation (SBO) using a new calcium silicate sealer in comparison with warm vertical compaction (WVC) using a resin-based sealer, which is the current gold standard.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must be 18-65 years of age at the time of recruitment
* Participants must have a classification of I or II on the American Society of Anesthesiologists (ASA) physical status classification system
* Participants must not have known allergies to any materials used in the study
* Participants must agree to participate in the study by signing a consent form
* Participants must have good oral hygiene
* Maxillary and mandibular permanent molar teeth that require primary root canal treatment will be included
* The teeth must be restorable and have fully formed roots with no advanced periodontal disease
Exclusion Criteria:
* ASA classification of III or more
* Pregnant or breastfeeding women
* Patients who are unable to give consent
* Patients who have advanced periodontal disease or teeth with more than 5mm probing
* Anterior, premolar and third molar teeth
* Teeth whose apices were over-enlarged at the time of pulp extirpation
* Teeth with broken instruments
* Teeth with blocked or non-negotiable canals
* Teeth with iatrogenic perforations
* Teeth with incomplete root formation
* Teeth with internal or external root resorption
* Teeth that have a poor restorative prognosis
* Teeth that require posts or extensive prosthetic rehabilitation
* Teeth with cracks
* Teeth that have been previously root-filled
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)
Timeframe: Change from baseline periapical lesion size at 12 months
2
Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms