Clinical trial NCT05279820: Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits
Official title: Full Versus Partial Pulpotomy in the Management of Teeth With Clinical Diagnosis of Irreversible Pulpits: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carious Exposure of Pulp
Irreversible Pulpitis
Pulpotomy
Keywords: irreversible pulpits
Pulpotomy
Outcome
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will run concurrently and the participants will randomly distributed between the two interventions using a block randomization procedure
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Aim: to compare the outcome of partial and full pulpotomy in managing carious pulp exposures in mature permanent teeth with symptoms of irreversible pulpitis

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

Eligibility criteria: 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

Primary outcomes:
measure: Post operative pain level measured by visual analogy scale from 0-10
timeFrame: 48 hours
measure: Post operative pain level measured by a numerical scale from 0-10
timeFrame: 48 hours
Secondary outcomes:
measure: Clinical success as measured by clinical examination
timeFrame: 6, 12, 24 months
measure: Radiographic success as evaluated by periapical x-rays
timeFrame: 6, 12, 24 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of science and technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Nessrin Taha, PhD
role: STUDY_CHAIR
References:
citation: 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.