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NCT Number: NCT07549620

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Cairo Governorate, 00202, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Score

    Time frame: 1 Week

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

Secondary outcomes

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

    Time frame: 1 Year

    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).

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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