Carious Exposure of Pulp, Irreversible Pulpitis, Pulpotomy
Conditions
Keywords
irreversible pulpits, Pulpotomy, Outcome
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
Interventions
PROCEDUREPartial pulpotomy
Partial pulp tissue amputation
PROCEDUREFull Pulpotomy
Full Pulpotomy
Sponsors
Jordan University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant will not be informed whether the treatment performed was partial or full pulpotomy the outcome assessor will be blinded to the type of treatment performed, and evaluation of the radiographs will include masking the crown so that the procedure cannot be identified.
Intervention model description
The study will run concurrently and the participants will randomly distributed between the two interventions using a block randomization procedure
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain level measured by visual analogy scale from 0-10 | 48 hours | scale from 0-10 |
| Post operative pain level measured by a numerical scale from 0-10 | 48 hours | scale from 0-10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success as measured by clinical examination | 6, 12, 24 months | The tooth should be pain free, no sinus tract or swelling, no tenderness to palpation as determined by clinical examination |
| Radiographic success as evaluated by periapical x-rays | 6, 12, 24 months | There should be no evidence of bone resorption or root resorption on the x-ray |
Countries
Jordan
Contacts
Primary ContactNessrin Taha, PhD
Backup ContactNessrin Taha, PhD
Outcome results
None listed