Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits
NCT ID: NCT05279820
Last Updated: 2022-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2021-06-01
2024-01-31
Brief Summary
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The study design will be a double blind randomized clinical trial.
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Detailed Description
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Methods: Assuming a 10% difference in the success rate in favor of pulpotomy, with 80% power and accounting for possible 10% attrition, the minimum sample size required is estimated to be 80 teeth in 80 patients in every arm.
Patients referred to the postgraduate Endodontic clinic for management of deep carious lesions with symptoms of irreversible pulpits will be assessed for inclusion in the study according to preset inclusion criteria. After a written informed consent baseline demographics of patients and teeth will be recorded.
Pulpotomy (partial or full using block randomization) will be performed under aseptic procedures and the tooth will be permanently restored. Post operative baseline radiographs will be taken.
Primary outcome will be assessed after 48 hours. secondary outcome will be assessed at 6 months, 1 year and 2 years post operatively.
Data of outcome and effect of preoperative and intraoperative variables on the outcome will be compared statistically using appropriate tests
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Partial Pulpotomy
After pulp exposure 2-3 mm of the pulp tissue will be amputated, a calcium silicate based material will be placed over the pulp and the tooth will be restored.
Partial pulpotomy
Partial pulp tissue amputation
Full Pulpotomy
After pulp exposure the entire coronal pulp to the level of canal orifices will be amputated , calcium silicate based material will be placed over the pulp and the tooth will be restored.
Full Pulpotomy
Full Pulpotomy
Interventions
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Partial pulpotomy
Partial pulp tissue amputation
Full Pulpotomy
Full Pulpotomy
Eligibility Criteria
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Inclusion Criteria
* 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
* necrotic teeth
* hemostasis could not be achieved within 8 minutes
10 Years
70 Years
ALL
Yes
Sponsors
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Jordan University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Nessrin Taha, PhD
Role: STUDY_CHAIR
Jordan University of Science and Technology
Locations
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Jordan University of science and technology
Irbid, , Jordan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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329/2021
Identifier Type: -
Identifier Source: org_study_id
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