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Active (not recruiting) Not applicable 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

No applicable phase (e.g. observational)
Conditions: Symptomatic Irreversible Pulpitis

Sponsor: Ain Shams University

trial.available_in: БГ
Overview
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.
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.
Who can participate
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.
Interventions
Vital Pulp Therapy
PROCEDURE
Root Canal Treatment
PROCEDURE
Locations 1
Egypt (1)
Ain Shams University
Cairo , Cairo Governorate
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
40 Years
Healthy volunteers
No
Start date
15.11.2025
Completion date
08.04.2027
Registry ID
NCT07549620
Source
clinicaltrials.gov
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