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The aim of the study is to compare the treatment outcome of pulpotomy using Biodentine or Portland cement regarding success rate and post-operative pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biodentine | Active Comparator | Biodentine (BD; Septodont, St Maur-des-Fosses, France) is a calcium silicate capping material. Biodentine is mixed according to manufacturer's instructions and placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed using a condenser. Initial setting is achieved after 12 minutes. |
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| Portland cement | Active Comparator | Preparation of Portland cement: Industrial Portland cement is mixed with Bisthmus oxide or Barium sulphate radio-opacifier in a 3:1 ratio. The mix is sieved through silk sieve then sterilized in hot air oven at 135 Ö¯C for 2 hours. Portland cement is mixed in a 3:1 powder: distilled water ratio and placed in the pulp chamber and condensed against a moist cotton pellet. A small cotton pellet moistened with saline is placed in the pulp chamber against PC for 5 seconds to ensure water uptake then removed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulpotomy | Procedure | Pulpotomy is the term for removal of the coronal pulp with the intent of maintaining the vitality of the remaining radicular pulp tissue. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pulpotomy Success rate | Clinical and radiographic evaluation is scheduled at 3 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration. | 3 months |
| Pulpotomy success rate | Clinical and radiographic evaluation is scheduled at 6 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration. | 6 months |
| Pulpotomy success rate | Clinical and radiographic evaluation is scheduled at 12 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | Patients will be contacted by telephone by the same operator to record pain intensity on Numerical Rating Scale (NRS) | 6, 12, 24, 48 hours and 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aya A Gamal, MSc | Contact | 01111078317 | aya.youssef@dentistry.cu.edu.eg | |
| Ghada Eid, phD | Contact | ghada.eid@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Aya A Gamal, MSc | Cairo University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30292451 | Background | Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3. | |
| 30981748 | Background | Li Y, Sui B, Dahl C, Bergeron B, Shipman P, Niu L, Chen J, Tay FR. Pulpotomy for carious pulp exposures in permanent teeth: A systematic review and meta-analysis. J Dent. 2019 May;84:1-8. doi: 10.1016/j.jdent.2019.03.010. Epub 2019 Apr 11. |
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| ID | Term |
|---|---|
| D011672 | Pulpotomy |
| ID | Term |
|---|---|
| D004708 | Endodontics |
| D003813 | Dentistry |
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| 16507075 | Background | Danesh G, Dammaschke T, Gerth HU, Zandbiglari T, Schafer E. A comparative study of selected properties of ProRoot mineral trioxide aggregate and two Portland cements. Int Endod J. 2006 Mar;39(3):213-9. doi: 10.1111/j.1365-2591.2006.01076.x. |