Clinical and Radiographic Evaluation of Primary Endodontic Treatment and Non-surgical Endodontic Retreatments

NCT07418840 | Not Yet Recruiting

• 1 other identifier: 7570
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periapical Periodontitis; Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 5 years

Secondary Outcomes (1)

• Secondary objective primary endodontic treatment and non-surgical endodontic retreatments survival rate

  From March 2026 through study completion, an average of 5 year

Other Outcomes (2)

• Patient-related outcomes evaluation using questionnaires

  1 year

• Assessing the correlation of systemic diseases and medical therapies with treatment outcomes.

  Through study completion, an average of 5 years

Interventions

Root canal treatment and non surgical endodontic retreatment PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Periapical Periodontitis; Pulpitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Dental Pulp Diseases; Tooth Diseases

Study Officials

• Luca Marigo

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Marigo

CONTACT

+393397630415; luca.marigo@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: February 18, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 15, 2031
• Study Completion (Estimated): October 15, 2032
• Last Updated: February 18, 2026

Record last verified: 2025-10