Clinical and Radiographic Evaluation of Primary Endodontic Treatment and Non-surgical Endodontic Retreatments (CR-ET)

February 11, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Clinical and Radiographic Evaluation of Primary Endodontic Treatments and Non-Surgical Endodontic Retreatments Performed in a Hospital Setting, a Prospective Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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.
  • Patients aged over 18 years.
  • Signed written informed consent to participate in the study.

Exclusion Criteria:

  • Inability to undergo consistent and continuous follow-up.
  • Patients with teeth affected by vertical root fractures.
  • Patients with teeth presenting periodontal compromise requiring extraction.
  • Pregnant or breastfeeding patients.
  • Inability to provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of of primary endodontic treatments and non-surgical endodontic retreatments using the Periapical Apex Index score.
Time Frame: Through study completion, an average of 5 years
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.
Through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary objective primary endodontic treatment and non-surgical endodontic retreatments survival rate
Time Frame: From March 2026 through study completion, an average of 5 year
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.
From March 2026 through study completion, an average of 5 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-related outcomes evaluation using questionnaires
Time Frame: 1 year
Other pre-specified Outcome is to evaluate the patient-related outcomes of the treatment. Patient-related outcomes will be measured using questionnaires.
1 year
Assessing the correlation of systemic diseases and medical therapies with treatment outcomes.
Time Frame: Through study completion, an average of 5 years
Other pre-specified outcome is to assess the influence of past or ongoing systemic diseases and/or therapies on the outcomes of endodontic treatment.
Through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Luca Marigo, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

March 15, 2031

Study Completion (Estimated)

October 15, 2032

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7570

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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