Comparative Analysis of Postoperative Pain in Symptomatic Irreversible Pulpitis Teeth Following Single Cone Obturation Using Three Different Sealers: A Randomized Clinical Trial
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis (SIP), Symptomatic Irreversible Pulpitis With Apical Peridontitis
Sponsor: Tehran University of Medical Sciences

Official Study Title: 
Comparative Analysis of Postoperative Pain in Symptomatic Irreversible Pulpitis Teeth Following 
Single Cone Obturation Using Three Different Sealers: A Randomized Clinical Trial 
Document Date: 4 May 2025 
Principal Investigator: Somayeh Majidi 
Institution: Tehran University of Medical Sciences, Faculty of Dentistry, Tehran, Iran 
Sponsor: Tehran University of Medical Sciences (100% funding) 
 
Study Protocol Summary 
1. Study Aim 
To assess and compare post-endodontic treatment pain in teeth with symptomatic irreversible pulpitis 
using two bioceramic sealers (EndoSeal TCS and NeoSeal) versus a resin-based sealer (AH Plus). 
2. Study Design 
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Phase 2, randomized, double-blind clinical trial with parallel groups. 
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Total sample size: 75 patients. 
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Randomization performed using Microsoft Excel’s rand function. 
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Double-blinded to ensure unbiased assessment of pain using the Visual Analog Scale (VAS). 
3. Study Setting 
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Conducted at Tehran University School of Dentistry clinics. 
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Objective: Identify optimal sealer types to minimize post-endodontic pain and guide clinical 
decisions. 
4. Participant Criteria 
Inclusion Criteria: 
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Age 18–60  years 
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Adequate oral hygiene 
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Prolonged positive response to cold/electric pulp testing 
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Diagnosis: Symptomatic irreversible pulpitis and symptomatic apical periodontitis in first or 
second molars 
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Pulp exposure during caries removal with significant hemorrhage 
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Teeth without radiographic periapical lesions, and with restorative potential 
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No periodontal disease 

Exclusion Criteria: 
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Teeth unsuitable for restoration (e.g., crown cannot be restored) 
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Endo-perio lesions, internal/external resorption, or calcified canals 
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Systemic diseases (ASA II or higher) 
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Use of anti-anxiety medications 
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Procedural duration > 2 hours 
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Allergies to treatment materials, including local anesthetics 
5. Intervention Groups 
1. Endoseal TCS – Bioceramic sealer 
2. NeoSeal – Bioceramic sealer 
3. AH Plus – Resin-based sealer (Control) 
6. Randomization and Blinding 
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Stratified randomization based on gender and pre-treatment analgesic consumption score 
(Low: 0–3, Moderate: 4–6, High: 7–10). 
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Patients select an envelope corresponding to their combination, ensuring even distribution 
across three groups. 
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Double-blinded: Neither operator nor patient knows sealer type during treatment; pain 
assessment performed by third-party evaluator. 
7. Outcome Measures 
Primary Outcome: 
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Post-endodontic pain intensity, measured using the Visual Analog Scale (VAS) 
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Timepoints: 0–6 hours post-treatment,12,18, 24 , 48 hours 
Secondary Outcomes: 
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Number of analgesic tablets consumed 
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Time and type of analgesic use 
8. Recruitment and Study Period 
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Recruitment status: Active 
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Location: Tehran University School of Dentistry Clinics 
9. Ethics and Regulatory Information 

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Ethics committee approval: Tehran University of Medical Sciences 
(IR.TUMS.DENTISTRY.REC.1404.021) 
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Approval date: 04 May 2025 
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Prospective registration: IRCT20250510065680N1, date 01 July 2025 
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Compliance: 42 CFR Part 11, Common Rule (45 CFR 46) 
10. Contacts 
Principal Investigator: Somayeh Majidi 
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Postgraduate Student of Endodontics, Faculty of Dentistry, Tehran University of Medical 
Sciences 
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Email: dr.somaiemajidi@yahoo.com 
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Phone: +98 21 4279 4000 
Scientific Contact: Shole Ghabraei, Associate Professor, Endodontics 
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Email: sholehghabraei@yahoo.com 
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Phone: +98 21 4279 4000 
Sponsor Contact: Dr. Ramin Kurdi, Tehran University of Medical Sciences 
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Phone: +98 21 4279 4000