NCT07066410

Evaluation of Two Different Calcium Silicate Cements as a Treatment for Irreversible Pulpitis in Mature Molars

Evaluation of the Effect of Different Calcium Silicate Cements on the Success of Vital Pulp Therapy in Irreversible Pulpal Infection Cases With Mature Roots: A Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: British University In Egypt · Academic / Other
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled clinical trial aims to evaluate the effect of two calcium silicate cements-Biodentine and EndoCem-on post-operative pain and treatment success in vital pulp therapy (VPT) for mature permanent mandibular molars diagnosed with irreversible pulpitis. A total of 50 patients will be randomly assigned into two groups to receive pulpotomy using either Biodentine or EndoCem. The trial is triple-blinded, self-funded, and conducted at the Endodontic Department, Faculty of Dentistry, The British University in Egypt.

Detailed description

This randomized controlled clinical trial investigates the impact of Biodentine and EndoCem on post-operative pain and treatment success in vital pulp therapy (VPT) of mature permanent mandibular molars with symptomatic irreversible pulpitis. VPT preserves the vitality of radicular pulp by removing inflamed coronal pulp tissue and capping the remaining healthy pulp with a biocompatible material. This conservative approach may maintain pulp vitality, reduce treatment time, and improve patient outcomes compared to conventional root canal treatment. Fifty eligible patients will be randomly assigned into two groups (n=25 per group). Pulpotomy will be performed under rubber dam isolation. After caries removal and coronal pulp amputation, hemostasis will be attempted with sterile saline-soaked cotton pellets. If bleeding persists beyond 5 minutes, the tooth will be excluded. The remaining pulp tissue will be capped with either Biodentine (Group 1) or EndoCem (Group 2), followed by immediate permanent restoration with composite resin to ensure a coronal seal. Eligibility Criteria Inclusion Criteria: * Patients aged 12-40 years. * Two-rooted mandibular molars diagnosed with symptomatic irreversible pulpitis. * Restorable teeth. * Periodontally healthy teeth (no mobility; negative percussion and palpation). * Ability to provide informed consent. Exclusion Criteria: * Teeth with immature roots. * Non-restorable teeth. * Uncontrolled bleeding from the pulp after pulpotomy for more than 10 minutes. * Necrotic teeth. * Medically compromised patients with systemic conditions affecting treatment. * Patients unable to provide informed consent. * Vulnerable populations (e.g., minors without guardian consent). Outcome Measures Primary Outcome: * Post-operative pain assessed using a Visual Analogue Scale (VAS; range 0-10, where 0 = no pain and 10 = worst possible pain). Time points: 6, 24, 48, and 72 hours post-treatment. Secondary Outcome: * Treatment success evaluated clinically (absence of pain, swelling, sinus tract) and radiographically (absence of periapical pathology) at 3 and 6 months.

Conditions

• Irreversible Pulpitis

Interventions

Type	Name	Description
BIOLOGICAL	intervention 1: endocem	EndoCem, a premixed calcium silicate-based cement (Maruchi, Korea), is used as the pulp capping material in vital pulp therapy (VPT). After achieving hemostasis with sterile saline-soaked cotton pellets, EndoCem is applied directly over the exposed radicular pulp tissue. The standardized clinical procedure includes local anesthesia, rubber dam isolation, caries removal, access cavity preparation, coronal pulp removal, and placement of EndoCem, followed by immediate restoration with FUJI II ensure a coronal seal.
BIOLOGICAL	Intervention 1: biodentine	Biodentine, a tricalcium silicate-based cement (Septodont, France), is used as the pulp capping material in vital pulp therapy (VPT). After achieving hemostasis with sterile saline-soaked cotton pellets, Biodentine is applied directly over the exposed radicular pulp tissue. The standardized clinical procedure includes local anesthesia, rubber dam isolation, caries removal, access cavity preparation, coronal pulp removal, and placement of Biodentine, followed by immediate restoration with FUJI II to ensure a coronal seal.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2025-07-15
• Last updated: 2025-07-22

Locations

1 site across 1 country: Egypt