Vital Pulp Therapy Versus Root Canal Treatment for Irreversible Pulpitis With Incipient Apical Periodontitis Diagnosed Using Artificial Intelligence This Keeps: the Main Intervention (Vital Pulp Therapy) the Comparison (Root Canal Treatment) the Condition (Irreversible Pulpitis With Incipient Apic

Impact of Vital Pulp Therapy in Acute Irreversible Pulpitis With Incipient Apical Periodontitis Cases Diagnosed by the Aid of Artificial Intelligence: A Randomized Controlled Clinical Trial

This study evaluates postoperative pain and treatment outcomes following vital pulp therapy and root canal treatment in patients with symptomatic teeth. Participants will receive either vital pulp therapy or standard root canal treatment, and pain will be measured using standardized pain scores at different time intervals after treatment.

The primary outcome is postoperative pain intensity in the early healing period. Secondary outcomes include long-term clinical and radiographic success at 6 months and 1 year.

Radiographic outcomes will be assessed using artificial intelligence (AI)-assisted analysis to improve evaluation of healing and treatment success.

The study aims to compare pain progression and long-term outcomes between the two treatment approaches.

Study Overview

• Status: Active, not recruiting
• Conditions: Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Procedure: Vital Pulp Therapy; Procedure: Root Canal Treatment

Detailed Description

This study is designed to evaluate postoperative pain and treatment outcomes following endodontic procedures, including both root canal treatment (RCT) and vital pulp therapy (VPT), in patients presenting with symptomatic pulpal conditions.

Participants will receive treatment according to clinical indication, either RCT or VPT. Postoperative pain will be assessed using standardized pain scoring systems at defined time intervals following treatment to evaluate short-term patient discomfort and recovery patterns.

The primary outcome measure is postoperative pain intensity following endodontic intervention during the early healing period.

Secondary outcomes include the long-term clinical and radiographic success of treated teeth, evaluated at 6 months and 1 year post-treatment.

Radiographic evaluation will be performed using standardized periapical radiographs, and outcomes will be assessed using artificial intelligence (AI)-assisted image analysis to support objective evaluation of periapical healing and treatment success.

The study aims to compare postoperative pain and treatment outcomes between RCT and vital pulp therapy, and to integrate AI-based radiographic assessment to improve the accuracy and consistency of outcome evaluation in endodontic treatment.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 00202
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Mandibular molars with with deep caries exposing the pulp and preoperative symptoms, such as spontaneous or referred pain.
• Mandibular molars lacking noticeable radiolucency in the furcation or periapical areas. (Periapical Index scores of 1 and 2)
• Patients aged 18-40 years with teeth diagnosed with acute irreversible pulpitis and symptomatic apical periodontitis.
• Patients willing to provide written informed consent for participation in the study.
• Restorable teeth and adequate periodontal support.

Exclusion Criteria:

• Teeth with prior endodontic treatment or history of trauma.
• Teeth with internal or external resorption, prominent radiolucency at the periapical regions or furcation. (Periapical Index score of 3, 4 and 5)
• Teeth that are not responsive to vitality tests.
• Pregnant or lactating women due to potential risks associated with radiographic exposure.
• Patients with systemic diseases (e.g., uncontrolled diabetes, immunosuppression) that may affect healing.
• Teeth with advanced periodontal disease (e.g., mobility grade II or III, furcation involvement).
• Patients unable to attend follow-up appointments for up to one year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vital Pulp Therapy; Participants receive vital pulp therapy for symptomatic teeth followed by postoperative pain assessment and radiographic follow-up.	Procedure: Vital Pulp Therapy; Vital pulp therapy will be performed on symptomatic teeth according to clinical indication to preserve pulp vitality. Postoperative pain will be assessed using standardized pain scoring methods, and radiographic healing will be evaluated using AI-assisted analysis.
Active Comparator: Root Canal Treatment; Participants receive conventional root canal treatment for symptomatic teeth followed by postoperative pain assessment and radiographic follow-up.	Procedure: Root Canal Treatment; Conventional root canal treatment will be performed on symptomatic teeth according to standard clinical protocols. Postoperative pain will be assessed using standardized pain scoring methods, and radiographic healing will be evaluated using AI-assisted analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Postoperative pain assessment using modified Visual Analogue Scale. Postoperative pain assessment after 24 hours and 1 week.	1 Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and AI- assisted Radiographic long term success rate of vital pulp therapy and Root Canal Treatment	Evaluations at 6 and 12 months for clinical signs and symptoms (presence or absence of pain or swelling) and AI- assisted radiographs (presence or absence of lesion).	1 Year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Abeer Elgendy, Professor, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2025
• Primary Completion (Actual): April 8, 2026
• Study Completion (Estimated): April 8, 2027

Study Registration Dates

• First Submitted: April 18, 2026
• First Submitted That Met QC Criteria: April 18, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Artificial intelligence; Postoperative pain; Pain assessment; Root canal treatment; Vital pulp therapy; Pulpitis; Endodontic treatment; Symptomatic teeth; AI radiographic analysis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Dental Pulp Diseases; Tooth Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Pulpitis
• Other Study ID Numbers: FDASU-Rec ID032513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because this is a single-center academic clinical study, and data sharing is not required by the study protocol or ethics approval. All published results will be reported in aggregate form to ensure participant confidentiality and data protection.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No