130 Participants NeededMy employer runs this trial

AH Plus Jet® for Root Canal

MF
Overseen ByMikaela Friberg
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dentsply Sirona Implants and Consumables
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two materials used in root canal treatments to determine which is more effective and safer. It compares a new sealer formula, AH Plus Jet® Endodontic Sealer, with the standard one. Individuals needing a root canal on their front or side teeth and having a good dental outlook for the next two years may qualify for this trial. Researchers will monitor participants for two years to evaluate treatment performance. As an unphased trial, this study allows participants to contribute to dental research and potentially benefit from innovative treatment options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that these endodontic sealers are safe for root canal treatment?

In a previous study, AH Plus Jet® root canal sealer provided a strong seal due to its excellent adhesion and stability. It remains in place and resists dissolution, which is crucial for safety. This sealer has been used in root canal treatments for over 30 years and is known for its strong adhesion and minimal shrinkage, helping to prevent leaks and infections.

The trial tests a new version of the AH Plus Jet® Endodontic Sealer, based on the original product. This suggests likely safety, as the original has been used safely in dental care for a long time. Previous research has not reported any major negative side effects, indicating that this treatment is generally safe for patients.12345

Why are researchers excited about this trial?

Researchers are excited about AH Plus Jet® because it introduces a modified formula as an endodontic sealer for root canal treatments. Unlike the standard sealers, AH Plus Jet® may offer improved sealing properties, which could lead to better long-term outcomes for patients by reducing the risk of bacterial leakage. This innovative approach could enhance the durability and success rate of root canal procedures, making it a promising development in dental care.

What evidence suggests that this trial's treatments could be effective for root canal treatment?

Research has shown that AH Plus Jet® sealers effectively seal root canals. For over 30 years, they have consistently prevented leaks. A strong seal is crucial to stopping future infections in treated teeth. Studies also indicate that AH Plus Jet® exhibits minimal shrinkage, maintaining a snug fit in the root canal over time. In this trial, one arm will test a new formula of the AH Plus Jet® endodontic sealer, designed to perform as well as or better than the original, while another arm will use the predicate device for comparison.12678

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who need a root canal on one or two mature front teeth or premolars, are able to understand the study, agree to participate and return for follow-ups, and whose treated tooth is expected to last at least two years.

Inclusion Criteria

I am willing and able to understand and join this clinical study.
My study tooth is expected to remain healthy for the next 2 years.
I need one or two root canals on my front or premolar adult teeth.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive root canal treatment using either the modified formula or predicate AH Plus Jet® Endodontic Sealer

1 day (single visit)
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessment of post-operative pain and coping strategies

24 months
Visits at 7 days, 6 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • AH Plus Jet® Endodontic Sealer
  • AH Plus Jet® Root Canal Sealing Material

Trial Overview

The study compares two types of AH Plus Jet® root canal sealers—one with a modified formula (ES) and the standard version (RCS)—using a single-cone technique. Each tooth will be randomly assigned to receive either sealer, with results tracked over 24 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Endodontic sealer material with a modified formulaExperimental Treatment1 Intervention
Group II: Predicate deviceActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dentsply Sirona Implants and Consumables

Lead Sponsor

Trials
68
Recruited
4,800+

Simon Campion

Dentsply Sirona Implants and Consumables

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. Patrizia Cavazzoni

Dentsply Sirona Implants and Consumables

Chief Medical Officer

MD from Harvard Medical School

Citations

AH Plus Root Canal Sealer

AH Plus root canal sealer achieves a superior endodontic seal and is compatible with warm and cold techniques. Learn more!

Clinical Performance of AH Plus Jet® Root Canal Sealers ...

AH Plus® endodontic sealer is a class IIa medical device used for permanent obturation of root canals of teeth of the secondary dentition in ...

Calcium silicate-based root canal sealers: a literature review

This review aims to summarize the properties of calcium silicate-based sealers and to compare them with those of the resin-based sealer, AH Plus. First, ...

AH Plus® Marks 30 Years of Use in Endodontics With ...

According to the manufacturer, AH Plus® has maintained a reputation for reliability as an endodontic sealer over the past three decades and ...

Comprehensive Review Of Current Endodontic Sealers - DUNE

Compared to AH Plus, tricalcium silicate sealers show the lowest relative microleakage among the sealers assessed, followed by silicone sealers and other non-AH ...

Comparative Study on the Microleakage of Three Root Canal ...

INTRODUCTION: The aim of this study was to examine and compare the apical sealing ability of AH26, AH Plus and AH Plus Jet using the fluid filtration model.

AH Plus Jet® for Root Canal · Info for Participants

A prospective, parallel-group, randomised, post-market clinical follow-up investigation evaluating the performance and safety of the ...

AH Plus® - Scientific Compendium

canal sealing material is to be used as permanent root canal sealer. AH Plus® root canal sealing material and AH Plus Jet® root canal sealing material are.