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The aim of this randomized controlled trial is to assess the post-operative pain as primary outcome and the success rate as secondary outcome after pulpotomy using different calcium silicate based materials in mature permanent teeth diagnosed with irreversible pulpitis.
Setting and location :
Out-patients clinic of Endodontic Department, Faculty of Dentistry, Ain Shams University
Patient allocation:
Using computer generated randomization (www.randome.org), the participants will allocated randomly into three groups .
The sequentially numbers that will be generated, will be placed in opaque envelope until the intervention and each participant will be asked to select an envelope that determine which group of intervention he will be assigned.
Patient Classification:
Patients will be randomly divided into three groups according to material used in pulpotomy Group (1) Biodentine (n=20) Group (2) theracal PT (n=20) Group (3) Neoputty (n=20)
Procedural steps:
Methods of evaluation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| biodentine | Active Comparator | pulptomy with biodentine |
|
| Theracal PT | Active Comparator | pulpotomy with Theracal PT |
|
| Neo Putty | Active Comparator | pulpotomy with Neo putty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vital pulp therapy | Procedure | pulpotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | pre-operative |
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | 6 hours following the end of the procedure. |
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | 12 hours following the end of the procedure. |
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | 24 hours following the end of the procedure. |
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | 48 hours following the end of the procedure. |
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | 72 hours following the end of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulpotomy success | clinical and radiographic absence of inflammation | 3 months after the intervention |
| Pulpotomy success | clinical and radiographic absence of inflammation |
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Inclusion Criteria:
Patients age between 20 and 40 years old.
Exclusion Criteria:
Teeth with immature roots
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Abdel Rahman m Hashem, phd | Contact | 226401884 | ahmed@endohashem.com | |
| Ahmed Abdel Rahman Hashem, phd | Contact | 226401884 | ahmed@endohashem.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Abdel Rahman Hashem, phd | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32553879 | Result | Haikal L, Ferraz Dos Santos B, Vu DD, Braniste M, Dabbagh B. Biodentine Pulpotomies on Permanent Traumatized Teeth with Complicated Crown Fractures. J Endod. 2020 Sep;46(9):1204-1209. doi: 10.1016/j.joen.2020.06.003. Epub 2020 Jun 15. |
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| 6 months after the intervention |
| Pulpotomy success | clinical and radiographic absence of inflammation | 9 months after the intervention |
| Pulpotomy success | clinical and radiographic absence of inflammation | 12 months after the intervention |
| Pulpotomy success | clinical and radiographic absence of inflammation | 18 months after the intervention |