Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

4 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

130

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • New York
      • New York, New York, Stati Uniti, 10010
        • New York University College of Dentistry
        • Contatto:
          • Matthew Malek

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Investigation medical Device 1 (IMD1)
Endodontic sealer material with a modified formula compared to the predicate.
Dispositivo: 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.
Comparatore attivo: Investigation medical Device 2 (IMD2)
Predicate endodontic sealer material.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Endodontic treatment success
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Endodontic treatment success
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Dentsply Sirona Implants and Consumables

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 maggio 2026

Completamento primario (Stimato)

30 marzo 2028

Completamento dello studio (Stimato)

30 marzo 2029

Date di iscrizione allo studio

Primo inviato

4 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • C-EN-24-019

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su AH Plus Jet® Endodontic Sealer

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in India

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi