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.
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.
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.
Parallel
AH Plus Jet® Endodontic Sealer
DeviceAH 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 Material
DeviceAH 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.
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.
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.
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.
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.
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).
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