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
Not provided
Not provided
the study will evaluate the clinical and radiological success of mature permanent anterior teeth pulpotomy in children and adolescents with signs of pulpitis using two different Biomimetic materials (NeoPutty® and Biodentine™) as a pulp dressing material in comparison to root canal treatment at 3, 6, 9 and 12 months follow up.
In this randomized controlled trial, A total number of 75 mature vital permanent anterior teeth with recent trauma or deep caries in children aged between 9 and 14 years will be included. Patients will be randomly allocated into three study groups: group A (premixed bioceramic NeoPutty®) test group, group B (Biodentine™) test group and group C (root canal treatment) control group. Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic or Biodentine™ according to the corresponding group then final composite restoration will be applied. Root canal treatment will be performed to the control group followed by composite restoration. Blinded clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: The premixed Bioceramic NeoPUTTY® group | Experimental | Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic NeoPUTTY® then final composite restoration will be applied. |
|
| Group B: The Biodentine™ group | Experimental | Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Biodentine™ then final composite restoration will be applied. |
|
| Group C: the root canal treatment group | Active Comparator | Root canal treatment will be performed to the control group followed by composite restoration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| premixed Bioceramic NeoPUTTY® | Procedure | Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic then final composite restoration will be applied. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success | Absence of pain related to the treated teeth, including patient reported pain or sensitivity to percussion/palpation. No evidence of swelling of supporting soft tissue or presence of sinus tract. Absence of excessive mobility affecting treated teeth. | 3, 6, 9 and 12 months follow up |
| Radiographic success | No Internal or external root resorption. No Periapical radiolucency. | 3, 6, 9 and 12 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of tooth discoloration. | Evaluation of tooth discoloration using the VITA Easyshade V digital spectrophotometer. | 3, 6, 9 and 12 months follow up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sally Emad, BDS,MSc | Contact | 01227788137 | sallyghobrial@dent.asu.edu.eg | |
| Dina Darwish, BDS,MSc, MD | Contact | dinadarwish@dent.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nagwa Khattab, BDS,MSc, MD | Ain Shams University | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D011671 | Pulpitis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C506393 | tricalcium silicate |
Not provided
Not provided
Not provided
two study groups and one control group
Not provided
Not provided
Double Blind study, where participants will be blinded to the study groups they are randomized to, statisticians will be blinded while performing statistical analysis. On the other hand, the operator/primary investigator cannot be blinded as she is already familiar with the tooth and materials used and their different application. Also, the outcome assessor is not blinded due to the difference between the used materials.
| Biodentine™ | Procedure | Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic or Biodentine™ according to the corresponding group then final composite restoration will be applied. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months. |
|
| Root canal treatment | Procedure | Root canal treatment will be performed to the control group followed by composite restoration. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months. |
|