Root Canal Treatment
Conditions
Brief summary
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.
Interventions
DEVICEAH 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.
DEVICEAH 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.
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of teeth with endodontic treatment success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of teeth with endodontic treatment success | 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. |
| Intensity of patient-reported short-term post-operative pain | 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. |
| Correlation between coping strategy scores and patient-reported short-term post-operative pain intensity levels - Active coping. | 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). |
| Correlation between coping strategy scores and patient-reported short-term post-operative pain intensity levels - Passive coping. | 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). |
| Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation. | 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. |
Countries
United States
Contacts
CONTACTMikaela Friberg
CONTACTUlrika Bonander
Outcome results
None listed