[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07642284":3,"trial-entities:NCT07642284":102,"trial-summary:NCT07642284":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":74,"locations":77,"central_contacts":90,"overall_officials":99,"references":100,"see_also_links":101},"NCT07642284","C-EN-24-019","Clinical Performance of AH Plus Jet® Root Canal Sealers in Single-cone Protocols","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","NOT_YET_RECRUITING","2029-03-30","2026-06","2026-06-16","2026-05-30","Dentsply Sirona Implants and Consumables","INDUSTRY",false,"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.",null,[19],"Root Canal Treatment",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},130,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","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.\n\nAH 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.",[34],"Endodontic sealer material with a modified formula",{"type":30,"name":36,"description":37,"armGroupLabels":38},"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.\n\nAH Plus Jet® Root Canal Sealing Material is a predicate to AH Plus Jet® Endodontic Sealer.",[39],"Predicate device",[41],{"measure":42,"description":43,"timeFrame":44},"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\u002FNo)\".\n\nThe endodontic treatment is considered a failure according to the loose criteria under any of the following criteria:\n\n* Need for intervention due to pain to percussion, palpation, or bite tests compared to the nearest contralateral tooth.\n* Sign of a swelling.\n* Sign of a sinus tract.\n* 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).",[46,49,52,56,60,63],{"measure":42,"description":47,"timeFrame":48},"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\u002FNo)\".\n\nThe endodontic treatment is considered a failure according to the loose criteria under any of the following criteria:\n\n* Need for intervention due to pain to percussion, palpation, or bite tests compared to the nearest contralateral tooth.\n* Sign of a swelling.\n* Sign of a sinus tract.\n* 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).",{"measure":42,"description":50,"timeFrame":51},"Endodontic treatment success according to strict criteria after 6 months, 1 and 2 years.\n\nThe endodontic treatment is considered a failure according to the strict criteria under any of the following criteria:\n\n* Need for intervention due to pain to percussion, palpation, or bite tests compared to the nearest contralateral tooth.\n* Sign of a swelling.\n* Sign of a sinus tract.\n* Periapical index (PAI) score \\>2.\n* 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).",{"measure":53,"description":54,"timeFrame":55},"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 +\u002F- 3 days after RCT visit (RCT visit conducted a maximum 2 months after day 0).",{"measure":57,"description":58,"timeFrame":59},"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.\n\nActive 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).",{"measure":61,"description":62,"timeFrame":59},"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.\n\nPassive 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).",{"measure":64,"description":65,"timeFrame":66},"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.","ALL","18 Years","75 Years",{"inclusion":71,"exclusion":72,"raw_text":73},[],[],"Inclusion Criteria:\n\n1. Adult aged 18-75 at time of informed consent.\n2. Subject willing to participate in the clinical investigation and able to understand the content of the clinical investigation.\n3. Subject willing to return for follow-up visits.\n4. Subject has signed and dated the informed consent form.\n5. Subject in need of one or two primary root canal treatment on mature permanent anterior (incisor or canine) or premolar tooth.\n6. Planned study tooth has a favorable prognosis for the next 2 years.\n\nExclusion Criteria:\n\n1. History of allergic reaction to epoxy resins or amines or any of the other product components.\n2. Subject has significant systemic health issues or chronic conditions (American Society of Anesthesiologists (ASA) class 3-6).\n3. Known pregnancy or is breastfeeding at time of enrolment or at the RCT visit.\n4. Subject unlikely to comply with investigational procedures, as judged by the Investigator.\n5. Sign of sinus tract or gingival swelling in the planned study position.\n6. Previous enrolment in the present clinical investigation.\n7. Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).\n8. Participation in another clinical investigation that may interfere with the present clinical investigation.\n9. Subject experiencing an intraoperative condition that may interfere with the evaluation of the investigational root canal sealer.",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"city":80,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":87},"New York University College of Dentistry","New York","10010","United States",[84],{"name":85,"role":86},"Matthew Malek","CONTACT",{"lat":88,"lon":89},40.71427,-74.00597,[91,95],{"name":92,"role":86,"phone":93,"email":94},"Mikaela Friberg","+46 702 644 357","mikaela.friberg@dentsplysirona.com",{"name":96,"role":86,"phone":97,"email":98},"Ulrika Bonander","+46 706 440 844","ulrika.bonander@dentsplysirona.com",[],[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Treatment of root canal of tooth",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]