An observational study in Periapical Periodontitis and Pulpitis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
Background:
Pulpitis 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.
Objectives:
The primary aim of this prospective study is to evaluate the success of primary and non-surgical endodontic retreatments performed in a hospital environment.
Secondary 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.
Methods:
This 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/chronic abscesses will be enrolled after providing written informed consent in accordance with the Declaration of Helsinki.
Exclusion criteria include inability to complete follow-up, vertical root fractures, advanced periodontal disease requiring extraction, pregnancy or breastfeeding, and inability to provide informed consent.
Patients 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.
Patient-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.
Outcome Measures:
The 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).
Secondary endpoints include the incidence of postoperative complications, survival rate of treated teeth, associations between systemic conditions and endodontic outcomes, and patient-reported outcome measures.
Statistical Analysis:
The 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.
Qualitative 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.
Associations 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.
Mixed-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 \< 0.05. Statistical analyses will be performed using IBM SPSS Statistics v25.0 (IBM Corp., Armonk, NY, USA).
Expected Results and Conclusions:
This 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.
280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.
This study's planned enrollment of 75 is below the median of 88 across 33 observational studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Patients over 18 years of age who require 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 will be selected.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Success of of primary endodontic treatments and non-surgical endodontic retreatments using the Periapical Apex Index score.
The primary objective of this study is to evaluate the success of primary endodontic treatments and non-surgical endodontic retreatments performed in a hospital setting. The success is defined by the absence of clinical symptoms and radiographic healing or maintenance of periapical health using the Periapical Apex Index score.
Time frame: Through study completion, an average of 5 years
Secondary objective primary endodontic treatment and non-surgical endodontic retreatments survival rate
The secondary objective of this study is to determine the survival rate of teeth undergoing primary endodontic treatments and non-surgical endodontic retreatments performed in a hospital setting. Survival rate is measured by assessing the presence or absence of the tooth in the dental arch at follow-up.
Time frame: From March 2026 through study completion, an average of 5 year
Patient-related outcomes evaluation using questionnaires
Other pre-specified Outcome is to evaluate the patient-related outcomes of the treatment. Patient-related outcomes will be measured using questionnaires.
Time frame: 1 year
Assessing the correlation of systemic diseases and medical therapies with treatment outcomes.
Other pre-specified outcome is to assess the influence of past or ongoing systemic diseases and/or therapies on the outcomes of endodontic treatment.
Time frame: Through study completion, an average of 5 years
No study locations are listed for this record.
Start is estimated for Mar 2026; primary completion for Mar 2031, 60 months later.
Of 16 observational studies under Periapical Periodontitis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's planned 60 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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