Symptomatic Irreversible Pulpitis
Conditions
Keywords
Vital pulp therapy, Root canal treatment, Endodontic treatment, Postoperative pain, Pain assessment, Symptomatic teeth, Pulpitis, AI radiographic analysis, Artificial intelligence
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.
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.
Interventions
PROCEDUREVital 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.
PROCEDURERoot 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.
Sponsors
Ain Shams University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 1 Week | Postoperative pain assessment using modified Visual Analogue Scale. Postoperative pain assessment after 24 hours and 1 week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and AI- assisted Radiographic long term success rate of vital pulp therapy and Root Canal Treatment | 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). |
Countries
Egypt
Contacts
STUDY_DIRECTORAbeer Elgendy, Professor
Ain Shams University
Outcome results
None listed