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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Endodontic sealer material with a modified formula 		Investigation medical Device 1 (IMD1). Endodontic sealer material with a modified formula compared to the predicate.
  • Device: 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.
Active Comparator
Predicate device 		Investigation medical Device 2 (IMD2). Predicate endodontic sealer material.
  • Device: 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.

Recruiting Locations

New York University College of Dentistry
New York, New York 10010
Contact:
Matthew Malek

More Details

Status
Recruiting
Sponsor
Dentsply Sirona Implants and Consumables

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.