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

NCT ID: NCT07066410

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

arm 1 Endocem group

Biological/Vaccine:

Patients will undergo pulpotomy using EndoCem (Maruchi, Korea) after achieving hemostasis. Same standardized clinical procedure as the Biodentine group, but with EndoCem material used for pulp capping and final restoration placement.

Group Type: EXPERIMENTAL

intervention 1: endocem

Intervention Type: BIOLOGICAL

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.

arm 2: Biodentine

Patients will undergo pulpotomy using Biodentine (Septodont, France) after achieving hemostasis. Standardized clinical procedure including anesthesia, rubber dam isolation, access cavity preparation, coronal pulp removal, and placement of Biodentine followed

Group Type: ACTIVE_COMPARATOR

Intervention 1: biodentine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• • Patient's age ranges from 12-40 years old.

• Two Rooted Mandibular Molar teeth diagnosed with symptomatic irreversible pulpitis
• The teeth are restorable
• Informed consent granted
• Teeth are periodontally free, with no mobility and negative to percussion and palpation test.

Exclusion Criteria

• Teeth with immature roots

• Non restorable teeth
• Bleeding could not be controlled after pulpotomy in 10 minutes
• Medically compromised patients with systemic complication that would alter the treatment.
• Necrotic teeth
• Inability to give informed consent

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

British University In Egypt

OTHER

Sponsor Role: lead

Responsible Party

Yassmin

Yasmeen El-shaarawi, BDS, MSc Candidate, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dental Clinic at the British University in Egypt Hospital

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

23-047

Identifier Type: -

Identifier Source: org_study_id