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

4. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

130

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • New York
      • New York, New York, Vereinigte Staaten, 10010
        • New York University College of Dentistry
        • Kontakt:
          • Matthew Malek

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Investigation medical Device 1 (IMD1)
Endodontic sealer material with a modified formula compared to the predicate.
Gerät: 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.
Aktiver Komparator: Investigation medical Device 2 (IMD2)
Predicate endodontic sealer material.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Endodontic treatment success
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Endodontic treatment success
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Dentsply Sirona Implants and Consumables

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. Mai 2026

Primärer Abschluss (Geschätzt)

30. März 2028

Studienabschluss (Geschätzt)

30. März 2029

Studienanmeldedaten

Zuerst eingereicht

4. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • C-EN-24-019

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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