[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625146":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":7,"responsibleParty":22,"collaborators":7,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":30,"eligibilityCriteria":31,"healthyVolunteers":26,"sex":32,"minAge":33,"maxAge":7,"enrollmentInfo":34,"targetDuration":7,"studyType":37,"phases":7,"briefSummary":38,"conditions":39,"keywords":7,"overallStatus":42,"whyStopped":7,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":7},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"PROCEDURE","Root canal treatment and non surgical endodontic retreatment","Endodontic treatment generally involves opening the access cavity of the affected tooth, locating the root canals, and exploring them with endodontic instruments. Subsequently, the canals are shaped using nickel-titanium instruments, irrigated with sodium hypochlorite (NaOCl) and EDTA, and filled with gutta-percha and root canal sealer. The endodontic procedure concludes with the post-endodontic restoration of the treated tooth.",[14],{"name":15,"affiliation":5,"role":16},"Luca Marigo","PRINCIPAL_INVESTIGATOR",[18],{"name":15,"role":19,"phone":20,"phoneExt":7,"email":21},"CONTACT","+393397630415","luca.marigo@policlinicogemelli.it",{"type":23,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100625146","clinical-and-radiographic-evaluation-of-primary-endodontic-treatment-and-non-surgical-endodontic-retreatments-100625146",false,"NCT07418840","Clinical and Radiographic Evaluation of Primary Endodontic Treatment and Non-surgical Endodontic Retreatments","Clinical and Radiographic Evaluation of Primary Endodontic Treatments and Non-Surgical Endodontic Retreatments Performed in a Hospital Setting, a Prospective Study","CR-ET","Inclusion Criteria:\n\n* Patients requiring primary endodontic treatment or non-surgical endodontic retreatment due to symptomatic or asymptomatic irreversible pulpitis, symptomatic or asymptomatic apical periodontitis, or an acute or chronic abscess.\n* Patients aged over 18 years.\n* Signed written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Inability to undergo consistent and continuous follow-up.\n* Patients with teeth affected by vertical root fractures.\n* Patients with teeth presenting periodontal compromise requiring extraction.\n* Pregnant or breastfeeding patients.\n* Inability to provide written informed consent.","ALL","18 Years",{"count":35,"type":36},75,"ESTIMATED","OBSERVATIONAL","Background:\n\nPulpitis and apical periodontitis are inflammatory conditions of the dental pulp and periapical tissues, primarily caused by microbial invasion. The global prevalence of pulpitis is considered high but underestimated, as up to 40% of cases are asymptomatic. Similarly, the prevalence of apical periodontitis varies widely (16-86%) depending on population characteristics, systemic conditions, and socioeconomic status, and it is reported to be higher in hospital settings. Endodontic therapy aims to disinfect and seal the root canal system, promoting healing of apical periodontitis or maintaining periapical health. Reported success rates for primary and non-surgical retreatment procedures are comparable (75% and 77%, respectively), though outcomes tend to be more favorable in vital teeth compared to those with apical periodontitis (84% vs. 75%). Despite the widespread use of endodontic therapy, few studies have assessed treatment outcomes in a hospital setting.\n\nObjectives:\n\nThe primary aim of this prospective study is to evaluate the success of primary and non-surgical endodontic retreatments performed in a hospital environment.\n\nSecondary objectives include assessing (1) the survival of treated teeth, (2) patient-related outcomes (PROs), and (3) the influence of systemic diseases or ongoing therapies on treatment outcomes.\n\nMethods:\n\nThis is a monocentric, prospective, observational, study to be conducted at the Dental Clinic of the A. Gemelli University Hospital, Rome. Adult patients (\\>18 years) requiring primary or non-surgical endodontic retreatment due to symptomatic or asymptomatic irreversible pulpitis, apical periodontitis, or acute\u002Fchronic abscesses will be enrolled after providing written informed consent in accordance with the Declaration of Helsinki.\n\nExclusion criteria include inability to complete follow-up, vertical root fractures, advanced periodontal disease requiring extraction, pregnancy or breastfeeding, and inability to provide informed consent.\n\nPatients will undergo standard endodontic therapy according to the European Society of Endodontology (ESE) guidelines. Clinical and radiographic evaluations will be performed preoperatively, intraoperatively, and postoperatively. Radiographic assessments will be based on the Periapical Index (PAI), and follow-ups will occur at 6 months, 1 year, and annually for up to 4 years, with a final clinical follow-up at 5 years.\n\nPatient-related outcomes will be evaluated using the Numerical Rating Scale (NRS-12) for pain and the Oral Health Impact Profile (OHIP-14) questionnaire before treatment and at 1, 3, and 7 days post-treatment.\n\nOutcome Measures:\n\nThe primary endpoint is the rate of endodontic success, defined by the absence of clinical symptoms (pain, swelling, sinus tract, tenderness) and radiographic healing or maintenance of periapical health (Periapical Apex Index, PAI).\n\nSecondary endpoints include the incidence of postoperative complications, survival rate of treated teeth, associations between systemic conditions and endodontic outcomes, and patient-reported outcome measures.\n\nStatistical Analysis:\n\nThe sample size was calculated according to Lachin et al., assuming an expected success rate of 85%, a 5% margin of error, and 90% power, resulting in a minimum of 74 patients.\n\nQualitative variables will be expressed as frequencies and percentages, while quantitative variables will be summarized as mean ± SD or median, depending on distribution. Normality will be tested with the Kolmogorov-Smirnov test.\n\nAssociations between categorical variables will be evaluated using Pearson's χ² or Fisher's exact test, and continuous variables with Student's t-test, Mann-Whitney U, ANOVA, or Kruskal-Wallis tests as appropriate. Repeated measures ANOVA or Friedman tests will be applied to detect longitudinal changes.\n\nMixed-effects models ((G)LMM) will be used to analyze changes in PAI, NRS-12, and OHIP-14 over time while adjusting for confounders. Logistic regression will identify independent predictors of success, and Kaplan-Meier survival curves (log-rank test) will estimate tooth survival over follow-up. Significance will be set at p \\\u003C 0.05. Statistical analyses will be performed using IBM SPSS Statistics v25.0 (IBM Corp., Armonk, NY, USA).\n\nExpected Results and Conclusions:\n\nThis study is expected to provide data on the clinical and radiographic success rates of primary and non-surgical endodontic treatments performed in a hospital setting. It will also clarify the impact of systemic diseases and patient-related factors on treatment outcomes. The findings may help optimize clinical protocols and patient management strategies in hospital-based endodontic care, contributing to evidence-based improvement of dental services and patient quality of life.",[40,41],"Periapical Periodontitis","Pulpitis","NOT_YET_RECRUITING","2026-02-11",{"date":45,"type":46},"2026-02-18","ACTUAL",{"date":48,"type":36},"2026-03-15",{"date":50,"type":36},"2032-10-15",{"name":5,"class":6}]