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

British University In Egypt

Status: Active, not recruiting

Conditions: Irreversible Pulpitis

Treatments: Biological: intervention 1: endocem; Biological: Intervention 1: biodentine

Study type: Interventional

Funder types: Other

Identifiers

NCT07066410

23-047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 12 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

arm 1 Endocem group

Experimental group

Description:

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.

Treatment:

Biological: intervention 1: endocem

arm 2: Biodentine

Active Comparator group

Description:

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

Treatment:

Biological: Intervention 1: biodentine