Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279820
• Other study ID #: 329/2021
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Carious Exposure of Pulp
• Irreversible Pulpitis
• Pulpitis
• Pulpotomy

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