Recruiting

ES vs. RCS

Sponsor:

Dentsply Sirona Implants and Consumables

Code:

NCT07642284

Conditions

Root Canal Treatment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AH Plus Jet® Endodontic Sealer

AH Plus Jet® Root Canal Sealing Material

Study Details

Brief 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.

Conditions

Root Canal Treatment

Study ID

NCT07642284

Start date

Sep 9, 2026

Status verified date

Sep, 2026

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult aged 18-75 at time of informed consent.
2. Subject willing to participate in the clinical investigation and able to understand the content of the clinical investigation.
3. Subject willing to return for follow-up visits.
4. Subject has signed and dated the informed consent form.
5. Subject in need of one or two primary root canal treatment on mature permanent anterior (incisor or canine) or premolar tooth.
6. Planned study tooth has a favorable prognosis for the next 2 years.

Exclusion Criteria:

1. History of allergic reaction to epoxy resins or amines or any of the other product components.
2. Subject has significant systemic health issues or chronic conditions (American Society of Anesthesiologists (ASA) class 3-6).
3. Known pregnancy or is breastfeeding at time of enrolment or at the RCT visit.
4. Subject unlikely to comply with investigational procedures, as judged by the Investigator.
5. Sign of sinus tract or gingival swelling in the planned study position.
6. Previous enrolment in the present clinical investigation.
7. Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).
8. Participation in another clinical investigation that may interfere with the present clinical investigation.
9. Subject experiencing an intraoperative condition that may interfere with the evaluation of the investigational root canal sealer.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Endodontic sealer material with a modified formula

Investigation medical Device 1 (IMD1). Endodontic sealer material with a modified formula compared to the predicate.

active comparator: Predicate device

Investigation medical Device 2 (IMD2). Predicate endodontic sealer material.

Interventions

AH Plus Jet® Endodontic Sealer

AH Plus® endodontic sealer is a class IIa medical device used for permanent obturation of root canals of teeth of the secondary dentition in combination with root canal points, for subjects in need of endodontic treatment to restore a tooth.

AH Plus Jet® Endodontic Sealer has similar intended use and the same indications for use as the predicate Root Canal Sealer (AH Plus Jet® Root Canal Sealing Material). However, there are minor differences in the technological characteristics.

AH Plus Jet® Root Canal Sealing Material

AH Plus® endodontic sealer is a class IIa medical device used for permanent obturation of root canals of teeth of the secondary dentition in combination with root canal points, for subjects in need of endodontic treatment to restore a tooth.

AH Plus Jet® Root Canal Sealing Material is a predicate to AH Plus Jet® Endodontic Sealer.

Primary outcome measure

  • Number of teeth with endodontic treatment success [ Time Frame: At 1 year after Root Canal Treatment (RCT) visit (RCT visit conducted a maximum 2 months after day 0). ]

Central Contacts and Locations

Central contacts

Mikaela Friberg

+46 702 644 357mikaela.friberg@dentsplysirona.com

Ulrika Bonander

+46 706 440 844ulrika.bonander@dentsplysirona.com

Locations

New York University College of Dentistry

Recruiting

New York, New York, United States, 10010

More Information

Sponsor

Dentsply Sirona Implants and Consumables

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Dentsply Sirona Implants and Consumables on 2026-09-11.