Irreversible Pulpitis Clinical Trial
Official title:
Full Versus Partial Pulpotomy in the Management of Teeth With Clinical Diagnosis of Irreversible Pulpits: A Randomized Clinical Trial
NCT number | NCT05279820 |
Other study ID # | 329/2021 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | January 2024 |
This study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. The primary outcome is resolution of symptoms and the secondary outcome is clinical and radiographic normality at 1 and 2 years follow up. The study design will be a double blind randomized clinical trial.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 2024 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 70 Years |
Eligibility | Inclusion Criteria: - Mature permanent tooth - Deep caries extending more than two thirds of dentine or exposing the pulp - Tooth responds positively to cold test - Clinical symptoms of irreversible pulpits - Tooth is restorable and can be restored with coronal restoration - Bleeding normally is confirmed after pulp exposure - hemostasis could be achieved within 8 minutes Exclusion Criteria: - Non restorable teeth - necrotic teeth - hemostasis could not be achieved within 8 minutes |
Country | Name | City | State |
---|---|---|---|
Jordan | Jordan University of science and technology | Irbid |
Lead Sponsor | Collaborator |
---|---|
Jordan University of Science and Technology |
Jordan,
Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post operative pain level measured by visual analogy scale from 0-10 | scale from 0-10 | 48 hours | |
Primary | Post operative pain level measured by a numerical scale from 0-10 | scale from 0-10 | 48 hours | |
Secondary | Clinical success as measured by clinical examination | The tooth should be pain free, no sinus tract or swelling, no tenderness to palpation as determined by clinical examination | 6, 12, 24 months | |
Secondary | Radiographic success as evaluated by periapical x-rays | There should be no evidence of bone resorption or root resorption on the x-ray | 6, 12, 24 months |
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