Clinical Performance of AH Plus Jet® Root Canal Sealers in Single-cone Protocols

NCT07642284 | Not Yet Recruiting FDA Device

• 1 other identifier: C-EN-24-019
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of teeth with endodontic treatment success

  Endodontic treatment success according to loose criteria after 1 year, defined as "Tooth with successful endodontic treatment according to loose criteria (Yes/No)". The endodontic treatment is considered a failure according to the loose criteria under any of the following criteria: * Need for intervention due to pain to percussion, palpation, or bite tests compared to the nearest contralateral tooth. * Sign of a swelling. * Sign of a sinus tract. * Unchanged or increased size or score of the radiolucent pathology on the radiograph.

  At 1 year after Root Canal Treatment (RCT) visit (RCT visit conducted a maximum 2 months after day 0).

Secondary Outcomes (6)

• Number of teeth with endodontic treatment success

  At 6 months and 2 years after RCT visit (RCT visit conducted a maximum 2 months after day 0).

• Number of teeth with endodontic treatment success

  At 6 months, 1 year and 2 years after RCT visit (RCT visit conducted a maximum 2 months after day 0).

• Intensity of patient-reported short-term post-operative pain

  At 7 days +/- 3 days after RCT visit (RCT visit conducted a maximum 2 months after day 0).

• Correlation between coping strategy scores and patient-reported short-term post-operative pain intensity levels - Active coping.

  At RCT visit and at 6 months, 1 year and 2 years after RCT visit (RCT visit conducted a maximum 2 months after day 0).

• Correlation between coping strategy scores and patient-reported short-term post-operative pain intensity levels - Passive coping.

  At RCT visit and at 6 months, 1 year and 2 years after RCT visit (RCT visit conducted a maximum 2 months after day 0).

Study Arms (2)

Endodontic sealer material with a modified formula

EXPERIMENTAL

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

Device: AH Plus Jet® Endodontic Sealer

Predicate device

ACTIVE COMPARATOR

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

Device: AH Plus Jet® Root Canal Sealing Material

Interventions

AH Plus Jet® Endodontic Sealer DEVICE

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.

Endodontic sealer material with a modified formula

AH Plus Jet® Root Canal Sealing Material DEVICE

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.

Predicate device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subject experiencing an intraoperative condition that may interfere with the evaluation of the investigational root canal sealer.

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (1)

New York University College of Dentistry

New York, New York, 10010, United States

Location

Central Study Contacts

Mikaela Friberg

CONTACT

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

Ulrika Bonander

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 11, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

US (1)