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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened
    • Start date changed from estimate of Sep 8, 2026 to Sep 9, 2026
    • Site details revised
    v4
  2. Start date: May 30, 2026 to Sep 8, 2026v3
  3. Primary endpoint(s) modified
    • Secondary endpoints revised (6)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07642284
Lead Sponsor Dentsply Sirona Implants and Consumables
Conditions
(from sponsor)		 Root Canal Treatment
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov