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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date March 2022
Source Jordan University of Science and Technology
Contact Nessrin Taha, PhD
Phone +962776566110
Email n.taha@just.edu.jo
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Partial pulpotomy
Partial pulp tissue amputation
Full Pulpotomy
Full Pulpotomy

Locations

Country Name City State
Jordan Jordan University of science and technology Irbid

Sponsors (1)

Lead Sponsor Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (1)

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

Outcome

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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