Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endodontic sealer material with a modified formula | Experimental | Investigation medical Device 1 (IMD1). Endodontic sealer material with a modified formula compared to the predicate. |
|
| Predicate device | Active Comparator | Investigation medical Device 2 (IMD2). Predicate endodontic sealer material. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AH Plus Jet® Endodontic Sealer | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| At 1 year after Root Canal Treatment (RCT) visit (RCT visit conducted a maximum 2 months after day 0). |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikaela Friberg | Contact | +46 702 644 357 | mikaela.friberg@dentsplysirona.com | |
| Ulrika Bonander | Contact | +46 706 440 844 | ulrika.bonander@dentsplysirona.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University College of Dentistry | New York | New York | 10010 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| AH Plus Jet® Root Canal Sealing Material | Device | 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. |
|
| At 6 months and 2 years after RCT visit (RCT visit conducted a maximum 2 months after day 0). |
| 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:
| 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 | 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. | 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. | 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. | 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. |