Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

4. juni 2026 opdateret af: Dentsply Sirona Implants and Consumables

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 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

130

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10010
        • New York University College of Dentistry
        • Kontakt:
          • Matthew Malek

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Investigation medical Device 1 (IMD1)
Endodontic sealer material with a modified formula compared to the predicate.
Enhed: 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.
Aktiv komparator: Investigation medical Device 2 (IMD2)
Predicate endodontic sealer material.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Endodontic treatment success
Tidsramme: 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.
At 1 year after Root Canal Treatment (RCT) visit (RCT visit conducted a maximum 2 months after day 0).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Endodontic treatment success
Tidsramme: At 6 months and 2 years after RCT visit (RCT visit conducted a maximum 2 months after day 0).

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

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

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).
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.
Tidsramme: 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).

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).
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.
Tidsramme: From Day 0 up to completion of the 2-year follow-up visit, on average 2 years and 2 months.
Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit.
From Day 0 up to completion of the 2-year follow-up visit, on average 2 years and 2 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dentsply Sirona Implants and Consumables

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. maj 2026

Primær færdiggørelse (Anslået)

30. marts 2028

Studieafslutning (Anslået)

30. marts 2029

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • C-EN-24-019

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rodbehandling

Kliniske forsøg med AH Plus Jet® Endodontic Sealer

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Senegal

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner