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

Part of paid clinical trials in New York, New York.

Sponsor
Dentsply Sirona Implants and Consumables
Study ID
NCT07642284
Status
Not Yet Recruiting

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Conditions

  • Root Canal Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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 subject will be included and "tooth" will be considered the statistical unit and hence considered independent even if they are in the same subject. They will be followed up for a period of 24 months to assess the outcomes.

Key Dates

Start date
May 30, 2026
Status verified
Jun 2026
Primary completion
Mar 30, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
New York University College of DentistryNew YorkNew York10010
Matthew Malek

Find similar trials in New York, NY

By research site
New York University College of Dentistry· New York, NY

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