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

NCT07549620 | Active Not Recruiting

• 1 other identifier: FDASU-Rec ID032513
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Vital pulp therapy; Root canal treatment; Endodontic treatment; Postoperative pain; Pain assessment; Symptomatic teeth; Pulpitis; AI radiographic analysis; Artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Postoperative pain assessment using modified Visual Analogue Scale. Postoperative pain assessment after 24 hours and 1 week.

  1 Week

Secondary Outcomes (1)

• Clinical and AI- assisted Radiographic long term success rate of vital pulp therapy and Root Canal Treatment

  1 Year

Study Arms (2)

Vital Pulp Therapy

ACTIVE COMPARATOR

Participants receive vital pulp therapy for symptomatic teeth followed by postoperative pain assessment and radiographic follow-up.

Procedure: Vital Pulp Therapy

Root Canal Treatment

ACTIVE COMPARATOR

Participants receive conventional root canal treatment for symptomatic teeth followed by postoperative pain assessment and radiographic follow-up.

Procedure: Root Canal Treatment

Interventions

Vital Pulp Therapy PROCEDURE

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.

Vital Pulp Therapy

Root Canal Treatment PROCEDURE

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.

Root Canal Treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 00202, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Pulpitis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Abeer Elgendy, Professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No participants, care providers, investigators, or outcome assessors were blinded to the assigned intervention. Radiographic analysis was performed using standardized methods with AI-assisted evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to one of two parallel study groups based on the treatment modality: vital pulp therapy or conventional root canal treatment. Each participant will receive only one intervention and will be followed prospectively to evaluate postoperative pain and treatment outcomes. The two groups will be assessed independently over the study period to compare clinical, radiographic, and patient-reported outcomes.

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: April 24, 2026
• Study Start: November 15, 2025
• Primary Completion: April 8, 2026
• Study Completion (Estimated): April 8, 2027
• Last Updated: April 24, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)