Predicting Local Anesthetic Success in Symptomatic Irreversible Pulpitis: A Machine Learning Study

NCT07672678 | Completed

• 1 other identifier: LA-PREDICT-SIP
• Study Type: observational
• Target: 4,390
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will develop and internally validate three machine learning models - logistic regression, random forest, and XGBoost - to predict local anesthetic (LA) success in patients undergoing endodontic treatment for symptomatic irreversible pulpitis (SIP). A large retrospective cohort of 4,390 consecutive adult patients treated at a single center (May 2014-October 2025) is being analyzed. The dataset was frozen in October 2025 for this analysis.

Conditions

Pulpitis; Nerve Block; Anesthesia, Local

Keywords

pulpitis; local anesthesia

Outcome Measures

Primary Outcomes (1)

• Local anesthetic (LA) success rate

  Proportion of patients achieving adequate pulpal anesthesia using the initial LA technique without supplemental injection. LA success defined as HP-VAS score \<54 mm on 170 mm scale AND no supplemental anesthetic required during access cavity preparation and root canal instrumentation.

  15 minutes Intraoperatively during endodontic treatment (from initiation of access cavity preparation to completion of root canal instrumentation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients (≥18 years) presenting for endodontic treatment with a clinical diagnosis of symptomatic irreversible pulpitis at a single dental teaching institution (Faculty of Dentistry, Jamia Millia Islamia, New Delhi, India) from May 2014 to October 2025.

You may qualify if:

• Adults (≥18 years) presenting with a clinical diagnosis of symptomatic irreversible pulpitis in a permanent tooth
• Diagnosis confirmed on the basis of patient-reported symptoms (spontaneous pain, lingering pain to thermal stimuli), clinical examination, and positive pulp sensibility testing (cold test and/or electric pulp test)
• Absence of radiographic evidence of periapical pathology
• ASA physical status I or II
• No prior local anesthetic injection for the same tooth within the preceding 24 hours
• No documented allergy or contraindication to amide local anesthetics

You may not qualify if:

• ASA physical status classification III or higher
• Pregnancy
• Confirmed radiographic periapical lesion or diagnosis of pulp necrosis
• Prior local anesthetic injection for the same tooth within the preceding 24 hours
• Documented allergy or contraindication to amide local anesthetics
• Age under 18 years
• Records with missing key predictor or outcome variables (9.2% of initially screened records excluded)

Sponsors & Collaborators

• Jamia Millia Islamia: lead

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Vivek Aggarwal

  Jamia Millia Islamia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Conservative Dentistry and Endodontics

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 29, 2026
• Study Start: May 1, 2014
• Primary Completion: October 16, 2025
• Study Completion: December 16, 2025
• Last Updated: June 29, 2026

Record last verified: 2026-06