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

NCT ID: NCT05279820

Last Updated: 2022-03-15

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-01-31

Brief Summary

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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

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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

Conditions

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Carious Exposure of Pulp Irreversible Pulpitis Pulpotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will run concurrently and the participants will randomly distributed between the two interventions using a block randomization procedure
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

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.

Group Type ACTIVE_COMPARATOR

Partial pulpotomy

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Full Pulpotomy

Intervention Type PROCEDURE

Full Pulpotomy

Interventions

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Partial pulpotomy

Partial pulp tissue amputation

Intervention Type PROCEDURE

Full Pulpotomy

Full Pulpotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jordan University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Nessrin Taha, PhD

Role: CONTACT

+962776566110

Nessrin Taha, PhD

Role: CONTACT

Facility Contacts

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Nessrin Taha, DCD

Role: primary

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.

Reference Type BACKGROUND
PMID: 32950193 (View on PubMed)

Other Identifiers

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329/2021

Identifier Type: -

Identifier Source: org_study_id

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