Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Exclusion Criteria:
Outcome Measures
Primary Outcome:
Secondary Outcome:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 Endocem group | Experimental | 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. |
|
| arm 2: Biodentine | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intervention 1: endocem | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Pain intensity measured using the Visual Analogue Scale (VAS), a 100 mm scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain | Time Frame: at 6 hours, 24 hours, 48 hours, and 72 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate | Teeth will be evaluated clinically for any signs or symptoms of pathosis including pain swelling sinus tract formation mobility and probing depth. teeth will be radiographically evaluated under optimum conditions, searching for periradicular pathosis, root resorption or internal resorption.Case will be considered successful if no clinical signs or symptoms and no radiographic sign of pathosis. |
Not provided
Inclusion Criteria:
• Patient's age ranges from 12-40 years old.
Exclusion Criteria:
Teeth with immature roots
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Clinic at the British University in Egypt Hospital | Cairo | Cairo Governorate | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Intervention 1: biodentine | 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. |
|
| follow up at 3 and 6 months |