[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658995":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":34,"studyPopulation":22,"armGroups":35,"interventions":66,"overallOfficials":22,"centralContacts":88,"locations":98,"responsibleParty":121,"collaborators":22,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":22,"eligibilityCriteria":128,"healthyVolunteers":125,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":22,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":144,"overallStatus":147,"whyStopped":22,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Ankara University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative Pain Intensity","Postoperative pain intensity will be assessed using a patient-reported Visual Analog Scale (VAS). The VAS consists of a 10-cm line anchored at 0 cm (\"no pain\") and 10 cm (\"worst imaginable pain\"). Participants will mark their pain intensity on the line. Scores will range from 0 to 10, with higher scores indicating greater pain intensity. The measurement unit will be the VAS score.","6, 12, 24, 48, and 72 hours and 7 days after completion of root canal treatment.",[14,18],{"measure":15,"description":16,"timeFrame":17},"Change in Oral Health-Related Quality of Life","Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire before treatment and 7 days after treatment. The questionnaire consists of 14 items, each scored from 0 (\"never\") to 4 (\"very often\"), yielding a total score ranging from 0 to 56. Higher scores indicate a greater adverse impact on oral health-related quality of life. Change will be calculated as the day-7 score minus the baseline score; negative values indicate improvement.","Baseline (before treatment) and 7 days after completion of root canal treatment.",{"measure":19,"description":20,"timeFrame":21},"Analgesic Consumption","Analgesic use for postoperative pain control will be recorded during the seven-day follow-up period and compared among the six treatment groups.","Within 7 days after completion of root canal treatment.",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":22,"timePerspective":22,"maskingInfo":28},"RANDOMIZED","PARALLEL","Participants are randomly assigned to one of six treatment groups in a 3 × 2 factorial design combining three irrigation agitation techniques (XP-Endo Finisher, EDDY, and passive ultrasonic activation) with two root canal sealers (AH Plus and NeoSealer Flo). Each group includes 54 participants, for a total of 324 participants. Each participant receives only one treatment combination, and root canal treatment is completed in a single visit. Postoperative pain, oral health-related quality of life, and analgesic use are evaluated over the same seven-day follow-up period and compared among the groups to assess the effects of each treatment factor and their interaction.","TREATMENT",{"masking":29,"maskingDescription":30,"whoMasked":31},"DOUBLE","The researcher performing the statistical analysis will be blinded to treatment assignments. The six treatment groups will be coded, and their identities will remain concealed from the researcher during data analysis. The treating clinician will not be blinded because of the differences between the irrigation agitation techniques and root canal sealers. Postoperative pain and oral health-related quality of life will be assessed using questionnaires completed by participants.",[32,33],"PARTICIPANT","OUTCOMES_ASSESSOR","This randomized clinical trial is designed to evaluate the effects of different irrigation agitation techniques and root canal sealers on postoperative pain and oral health-related quality of life in patients with symptomatic irreversible pulpitis. The study will compare six treatment combinations involving three irrigation agitation techniques and two root canal sealers. It will also investigate whether the two treatment factors have interacting effects on postoperative pain.\n\nStudy Design The study will be conducted as a randomized clinical trial with a 3 × 2 factorial design and six treatment groups. A total of 324 participants will be allocated equally to the groups, with 54 participants per group. Root canal treatment will be completed in a single visit by the same clinician using standardized clinical procedures.\n\nA computer-generated randomization sequence prepared by an independent researcher will be used to assign participants to the treatment groups. The treating clinician cannot be blinded because of the differences between the irrigation agitation techniques and sealers. Statistical analysis will be performed by a researcher blinded to group identities using coded treatment groups.\n\nParticipants Participants will be adults aged 18-65 years who require primary root canal treatment of a single-rooted, single-canal permanent tooth diagnosed with symptomatic irreversible pulpitis. Eligible teeth must show no evidence of apical pathology on periapical radiographs. Participants must be able to complete the patient-reported assessment tools and provide written informed consent before enrollment.\n\nExclusion criteria will include analgesic or antibiotic use within the preceding 48 hours, pregnancy or breastfeeding, periodontal disease, cracked teeth, internal resorption, and previous endodontic treatment of the study tooth.\n\nInterventions\n\nAll participants will undergo root canal treatment using standardized procedures for local anesthesia, isolation, canal preparation, irrigation, and obturation. Participants will receive one of the following treatment combinations:\n\n1. XP-Endo Finisher irrigation agitation with AH Plus.\n2. EDDY sonic irrigation agitation with AH Plus.\n3. Passive ultrasonic activation with AH Plus.\n4. XP-Endo Finisher irrigation agitation with NeoSealer Flo.\n5. EDDY sonic irrigation agitation with NeoSealer Flo.\n6. Passive ultrasonic activation with NeoSealer Flo. AH Plus is an epoxy resin-based root canal sealer, whereas NeoSealer Flo is a calcium silicate-based root canal sealer. The assigned irrigation agitation technique will be used during the irrigation stage, and the assigned sealer will be used during root canal obturation.\n\nFollow-up and Pain Assessment Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. Participants will record their pain intensity at 6, 12, 24, 48, and 72 hours and 7 days after completion of treatment using standardized follow-up forms.\n\nAnalgesic use during the seven-day follow-up period will also be recorded. Appropriate analgesic treatment will be provided when clinically indicated.\n\nOral Health-Related Quality of Life Assessment Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire before treatment and 7 days after treatment. The questionnaire contains 14 items addressing the impact of oral conditions on daily functioning and well-being. Higher scores indicate a greater adverse impact on oral health-related quality of life. Changes from baseline to day 7 will be compared among the treatment groups.\n\nOutcome Measures The primary outcome measure will be postoperative pain intensity assessed using the VAS at the specified follow-up time points.\n\nSecondary outcome measures will include changes in OHIP-14 scores from baseline to 7 days after treatment and analgesic consumption during the postoperative follow-up period. The relationship between postoperative pain and oral health-related quality of life will also be examined.\n\nStudy Objective The primary objective is to compare the effects of XP-Endo Finisher, EDDY, and passive ultrasonic activation, each used with either AH Plus or NeoSealer Flo, on postoperative pain in patients with symptomatic irreversible pulpitis. Additional objectives are to evaluate oral health-related quality of life, analgesic consumption, and the interaction between irrigation agitation technique and root canal sealer.\n\nThe findings may provide clinically relevant evidence to guide treatment selection and improve patient comfort following root canal treatment.",[36,43,48,53,58,62],{"label":37,"type":38,"description":39,"interventionNames":40},"XP-Endo Finisher + AH Plus","EXPERIMENTAL","Participants will receive single-visit root canal treatment with XP-Endo Finisher irrigation agitation, followed by root canal obturation using the epoxy resin-based sealer AH Plus.",[41,42],"Drug: XP-Endo Finisher","Drug: AH Plus",{"label":44,"type":38,"description":45,"interventionNames":46},"EDDY + AH Plus","Participants will receive single-visit root canal treatment with EDDY sonic irrigation agitation, followed by root canal obturation using the epoxy resin-based sealer AH Plus.",[47,42],"Drug: EDDY",{"label":49,"type":38,"description":50,"interventionNames":51},"Passive Ultrasonic Activation + AH Plus","Participants will receive single-visit root canal treatment with passive ultrasonic activation of the irrigant, followed by root canal obturation using the epoxy resin-based sealer AH Plus.",[52,42],"Drug: Passive Ultrasonic Activation",{"label":54,"type":38,"description":55,"interventionNames":56},"XP-Endo Finisher + NeoSealer Flo","Participants will receive single-visit root canal treatment with XP-Endo Finisher irrigation agitation, followed by root canal obturation using the calcium silicate-based sealer NeoSealer Flo.",[41,57],"Drug: NeoSealer Flo",{"label":59,"type":38,"description":60,"interventionNames":61},"EDDY + NeoSealer Flo","Participants will receive single-visit root canal treatment with EDDY sonic irrigation agitation, followed by root canal obturation using the calcium silicate-based sealer NeoSealer Flo.",[47,57],{"label":63,"type":38,"description":64,"interventionNames":65},"Passive Ultrasonic Activation + NeoSealer Flo","Participants will receive single-visit root canal treatment with passive ultrasonic activation of the irrigant, followed by root canal obturation using the calcium silicate-based sealer NeoSealer Flo.",[52,57],[67,72,76,80,84],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":22},"DRUG","XP-Endo Finisher","XP-Endo Finisher will be used to agitate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.",[37,54],{"type":68,"name":73,"description":74,"armGroupLabels":75,"otherNames":22},"EDDY","EDDY will be used for sonic agitation of the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.",[44,59],{"type":68,"name":77,"description":78,"armGroupLabels":79,"otherNames":22},"Passive Ultrasonic Activation","Passive ultrasonic activation will be used to activate the irrigant during single-visit root canal treatment of teeth with symptomatic irreversible pulpitis.",[49,63],{"type":68,"name":81,"description":82,"armGroupLabels":83,"otherNames":22},"AH Plus","AH Plus, an epoxy resin-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique.",[44,49,37],{"type":68,"name":85,"description":86,"armGroupLabels":87,"otherNames":22},"NeoSealer Flo","NeoSealer Flo, a calcium silicate-based root canal sealer, will be used during root canal obturation following the assigned irrigation agitation technique.",[59,63,54],[89,94],{"name":90,"role":91,"phone":92,"phoneExt":22,"email":93},"Emine ODABAŞI TEZER, DDS","CONTACT","+90 505 303 93 96","emiodabasi@gmail.com",{"name":95,"role":91,"phone":96,"phoneExt":22,"email":97},"ÖZGE KURT KAYA","+90 5457737969","Ozgekrtrs@gmail.com",[99],{"facility":100,"status":22,"city":101,"state":101,"zip":102,"country":103,"countryCode":22,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Ankara University Faculty of Dentistry","Ankara","06100","Turkey (Türkiye)",{"type":105,"coordinates":106},"Point",[107,108],32.85427,39.91987,{"lat":108,"lon":107},[111,113,115,117,119],{"name":112,"role":91,"phone":92,"phoneExt":22,"email":93},"Assistant Professor",{"name":114,"role":91,"phone":96,"phoneExt":22,"email":97},"ÖZGE KURT KAYA, DDS",{"name":90,"role":116,"phone":22,"phoneExt":22,"email":22},"PRINCIPAL_INVESTIGATOR",{"name":114,"role":118,"phone":22,"phoneExt":22,"email":22},"SUB_INVESTIGATOR",{"name":120,"role":118,"phone":22,"phoneExt":22,"email":22},"Elif SOLAKOĞLU, DDS",{"type":116,"investigatorFullName":122,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Assist.Prof.Emine ODABAŞI TEZER","100658995","effects-of-different-root-canal-filling-materials-and-irrigation-agitation-techniques-on-postoperative-pain-in-teeth-with-irreversible-pulpitis-a-randomized-clinical-trial-100658995",false,"NCT07859384","Effects of Different Root Canal Filling Materials and Irrigation Agitation Techniques on Postoperative Pain in Teeth With Irreversible Pulpitis: A Randomized Clinical Trial","Inclusion Criteria:\n\n* • Patients with single-rooted teeth requiring endodontic retreatment.\n\n  * Individuals in good general health, classified as ASA Physical Status I.\n  * Teeth presenting normal anatomical structure and root morphology.\n\nExclusion Criteria:\n\n* Patients who have used antibiotics or analgesic medications within the last month.\n\n  * Pregnant individuals and patients with systemic diseases (such as chronic illnesses, diabetes mellitus, hypertension).\n  * Teeth with root fractures or perforations.\n  * Patients presenting with high baseline pain levels, particularly those with a history of treatment-resistant pain.","ALL","18 Years","65 Years",{"count":133,"type":134},324,"ESTIMATED","INTERVENTIONAL",[137],"NA","This clinical study is designed to evaluate the effects of different irrigation agitation techniques and root canal sealers on postoperative pain and oral health-related quality of life in patients with symptomatic irreversible pulpitis. Postoperative pain following root canal treatment may affect patient comfort and satisfaction. The choice of irrigation agitation technique and root canal sealer may influence these outcomes. Irrigation agitation techniques are used to improve cleaning of the root canal system. XP-Endo Finisher, EDDY, and passive ultrasonic activation use different mechanisms to enhance this process. Root canal sealers, including the epoxy resin-based AH Plus and the calcium silicate-based NeoSealer Flo, also differ in their composition and biological properties. Clinical evidence regarding the combined effects of these techniques and sealers on patient-reported outcomes remains limited. In this randomized clinical trial, 324 patients aged 18-65 years requiring root canal treatment for a single-rooted, single-canal permanent tooth with symptomatic irreversible pulpitis will be allocated to six groups. Each group will receive one of three irrigation agitation techniques-XP-Endo Finisher, EDDY, or passive ultrasonic activation-in combination with either AH Plus or NeoSealer Flo. Root canal treatment will be completed in a single visit. Postoperative pain intensity will be assessed using a visual analog scale at 6, 12, 24, 48, and 72 hours and 7 days after treatment. Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 questionnaire before treatment and 7 days afterward. Analgesic use during the follow-up period will also be recorded. The primary objective is to compare postoperative pain among the six treatment groups. Secondary objectives include evaluating changes in oral health-related quality of life and analgesic consumption. The study will also investigate whether irrigation agitation techniques and root canal sealers have interacting effects on postoperative pain. The findings may help clinicians select irrigation agitation techniques and root canal sealers that support patient comfort and improve the patient experience following root canal treatment.",[140,141,142,143],"Postoperative Pain After Endodontic Treatment","Oral Health-Related Quality of Life","Symptomatic Irreversible Pulpitis","Endodontic Treatment",[142,145,146,141],"Postoperative Pain","Irrigation Agitation","NOT_YET_RECRUITING","2026-09-30",{"date":150,"type":151},"2026-10-05","ACTUAL",{"date":153,"type":134},"2026-11-13",{"date":155,"type":134},"2027-02-23",{"name":5,"class":6},1]