Root Canal TreatmentNCT07642284
Clinical Performance of AH Plus Jet® Root Canal Sealers in Single-cone Protocols
A study testing AH Plus Jet® Endodontic Sealer and AH Plus Jet® Root Canal Sealing Material in people with Root Canal Treatment, run by Dentsply Sirona Implants and Consumables at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Root Canal Treatment
- What is being tested?
- AH Plus Jet® Endodontic Sealer and AH Plus Jet® Root Canal Sealing Material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2026to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York University College of Dentistry
New York, New York, 10010
Matthew Malek
About this study
Official title: A Prospective, Parallel-group, Randomized Clinical Investigation Evaluating Performance and Safety of the AH Plus Jet® Sealing Materials Used in Single-cone Technique for Single Visit Endodontic Treatment. A 2-year Follow-up Study
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
- Being tested
- AH Plus Jet® Endodontic Sealer, AH Plus Jet® Root Canal Sealing Material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AH Plus Jet® Endodontic SealerDevice
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 MaterialDevice
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 group | Role | What they receive |
|---|---|---|
| Endodontic sealer material with a modified formula | Experimental | Investigation medical Device 1 (IMD1). Endodontic sealer material with a modified formula compared to the predicate. Receives: Device: AH Plus Jet® Endodontic Sealer |
| Predicate device | Active comparator | Investigation medical Device 2 (IMD2). Predicate endodontic sealer material. Receives: Device: AH Plus Jet® Root Canal Sealing Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Endodontic treatment success according to loose criteria after 6 months and 2 years, 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.
Measured: 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
Endodontic treatment success according to strict criteria after 6 months, 1 and 2 years.
The endodontic treatment is considered a failure according to the strict 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.
- Periapical index (PAI) score >2.
- Radiolucent pathology visible on radiograph.
Measured: 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
Short-term self-reported post-operative pain level of study tooth using Numeric Rating Scale (NRS) 0-10, where 0 is no pain and 10 is worst possible pain.
Measured: 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.
Patient completed questionnaire consisting of 27 questions. The patient will have an option to select a number between 0-6 in response to each question where a 0 indicates you never do that when you experience pain, a 3 indicates you sometimes do that when you experience pain, and a 6 indicates you always do it when you are experiencing pain. The scores will be categorized into mean values resulting in "active coping" or "passive coping" as listed below and will be correlated to patient-reported short-term post-operative pain intensity levels.
Active Coping is the mean of the following categories; Diverting Attention (questions 2, 15, 16, 25 and 26), Reinterpreting Pain Sensations (questions 1, 9, 18 and 27), Coping Statements (questions 4, 5, 11 and 20), and Ignoring Pain Sensations (questions 10, 12, 13, 19 and 22).
Measured: 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.
Patient completed questionnaire consisting of 27 questions. The patient will have an option to select a number between 0-6 in response to each question where a 0 indicates you never do that when you experience pain, a 3 indicates you sometimes do that when you experience pain, and a 6 indicates you always do it when you are experiencing pain. The scores will be categorized into mean values resulting in "active coping" or "passive coping" as listed below and will be correlated to patient-reported short-term post-operative pain intensity levels.
Passive Coping is the mean of the following categories; Praying \& Hoping (questions 8, 17 and 23) and Catastrophizing (questions 3, 6, 7, 14, 21 and 24).
Measured: 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).
Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.
Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit.
Measured: From Day 0 up to completion of the 2-year follow-up visit, on average 2 years and 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start9 Sep 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642284
- Sponsor's protocol ID
- C-EN-24-019
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Parallel-group, Randomized Clinical Investigation Evaluating Performance and Safety of the AH Plus Jet® Sealing Materials Used in Single-cone Technique for Single Visit Endodontic Treatment. A 2-year Follow-up Study
- ClinicalTrials.gov ID
- NCT07642284
- Acronym / sponsor ID
- C-EN-24-019
- Conditions
- Root Canal Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endodontic sealer material with a modified formula | Experimental | Device: AH Plus Jet® Endodontic SealerInvestigation medical Device 1 (IMD1). Endodontic sealer material with a modified formula compared to the predicate. |
| Predicate device | Active comparator | Device: AH Plus Jet® Root Canal Sealing MaterialInvestigation medical Device 2 (IMD2). Predicate endodontic sealer material. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AH Plus Jet® Endodontic SealerAH 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. | Device | Endodontic sealer material with a modified formula |
| AH Plus Jet® Root Canal Sealing MaterialAH 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. | Device | Predicate device |
Primary outcome
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).
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.
6 secondary outcomes
Number of teeth with endodontic treatment success
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.
Time frame: From Day 0 up to completion of the 2-year follow-up visit, on average 2 years and 2 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AH Plus Jet® Endodontic Sealer and AH Plus Jet® Root Canal Sealing Material in people with Root Canal Treatment, run by Dentsply Sirona Implants and Consumables at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikaela Friberg (+46 702 644 357, mikaela.friberg@dentsplysirona.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.