Clinical Performance of AH Plus Jet® Root Canal Sealers in Single-cone Protocols (NCT07642284) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Performance of AH Plus Jet® Root Canal Sealers in Single-cone Protocols
United States130 participantsStarted 2026-05-30
Plain-language summary
A prospective, parallel-group, randomised, post-market clinical follow-up investigation evaluating the performance and safety of the modified formula of the AH Plus Jet® Endodontic Sealer (also referred to as ES) and the predicate AH Plus Jet® Root Canal Sealing material (also referred to as RCS). Around 150 teeth will be randomly assigned to receive either ES or RCS root canal treatment using the single-cone technique. A maximum of 2 teeth per participant will be included and "tooth" will be considered the statistical unit and hence considered independent even if the teeth are in the same participant. Participants will be followed up for a period of 24 months to assess the outcomes.
Who can participate
Age range
18 Years – 75 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
. Adult aged 18-75 at time of informed consent.
. Subject willing to participate in the clinical investigation and able to understand the content of the clinical investigation.
. Subject willing to return for follow-up visits.
. Subject has signed and dated the informed consent form.
. Subject in need of one or two primary root canal treatment on mature permanent anterior (incisor or canine) or premolar tooth.
. Planned study tooth has a favorable prognosis for the next 2 years.
Exclusion criteria
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
Number of teeth with endodontic treatment success
Timeframe: At 1 year after Root Canal Treatment (RCT) visit (RCT visit conducted a maximum 2 months after day 0).
. History of allergic reaction to epoxy resins or amines or any of the other product components.
. Subject has significant systemic health issues or chronic conditions (American Society of Anesthesiologists (ASA) class 3-6).
. Known pregnancy or is breastfeeding at time of enrolment or at the RCT visit.
. Subject unlikely to comply with investigational procedures, as judged by the Investigator.
. Sign of sinus tract or gingival swelling in the planned study position.
. Previous enrolment in the present clinical investigation.
. Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).
. Participation in another clinical investigation that may interfere with the present clinical investigation.