Efficacy of PRF and MTA as Compared to Calcium Hydroxide for Pulpotomy in Human Irreversibly Inflamed Permanent Teeth

NCT ID: NCT05266859

Last Updated: 2022-08-17

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-28

Study Completion Date

2022-01-14

Brief Summary

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Of all the various pulpotomy medicaments that have been studied till to date, three agents have been selected for this study to compare their efficacy. CH being the control, MTA being one of the most recommended biomaterial and PRF that in addition to being a biomaterial is an autologous agent. Uptil now there have been no prospective trials using these three pulpotomy agents in mature permanent teeth with irreversible pulpitis in our part of the world and even the international studies that have been done utilized different methodologies with no unanimous conclusion. This is the reason that at present this treatment regime (pulpotomy) showing better perspectives cannot be presented with confidence as a predictable treatment option to the patients with irreversible pulpitis. By virtue of this study this challenge is being undertaken.

Hypothesis:

ALTERNATE HYPOTHESIS There is a difference between the efficacy of the PRF, MTA and CH when used as pulpotomy medicaments in mature permanent teeth with irreversible pulpitis NULL HPOTHESIS There is no difference in efficacy of the PRF, MTA and CH when used as pulpotomy medicaments in mature permanent teeth with irreversible pulpitis

Detailed Description

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Conditions

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Pulpitis - Irreversible Tooth Decay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group I- Calcium hydroxide (Control)

Group I will receive Calcium hydroxide . Calcium hydroxide is a gold standard medicament for the pulpotomy in deciduous teeth. It has antibacterial effects and widely used to disinfect the root canals.

This group will act as a control

Group Type ACTIVE_COMPARATOR

Calcium hydroxide

Intervention Type OTHER

Calcium hydroxide in the power/liquid form will be used and placed on the exposed pulp

Group II- MTA (Experimental)

Group II will receive MTA (Mineral Trioxide Aggregate). MTA is a calcium silicate based highly biocompatible material that is commonly used for pulpotomies in deciduous teeth along with the regenerative procedures in permanent and deciduous teeth

Group Type EXPERIMENTAL

MTA

Intervention Type OTHER

Mineral trioxide aggregate will be used as a powder / liquid form and placed over the exposed pulp

Group III- PRF (Experimental)

Group III will receive PRF. PRF is platelet-rich fibrin that is a biocompatible product derived from patient's own blood. It is formed by centrifugation of the blood of the patient. It provides the growth factors and promotes regeneration of the pulp

Group Type EXPERIMENTAL

PRF

Intervention Type OTHER

PRF will be placed directly over the exposed pulp

Interventions

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Calcium hydroxide

Calcium hydroxide in the power/liquid form will be used and placed on the exposed pulp

Intervention Type OTHER

MTA

Mineral trioxide aggregate will be used as a powder / liquid form and placed over the exposed pulp

Intervention Type OTHER

PRF

PRF will be placed directly over the exposed pulp

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with permanent teeth with completely formed roots diagnosed with irreversible pulpitis i.e. showing signs and symptoms as spontaneous, lingering pain initiated by hot and cold stimulus and /or radiating. Pulp being exposed or near to exposure by caries or alternatively by trauma.

Exclusion Criteria

* CLINICALLY Teeth with

* Necrotic pulp
* History of swelling, abscess , fistula and/ or sinus tract
* Doubtful restorability as indicated by over all Dental Practicality Index- (DPI) \> 2 (Dawood and Patel 2017) will be excluded
* Periodontal disease
* Uncontrolled bleeding (more that 10 mins.) of pulp after removal of inflamed part.
* No bleeding of pulp at all after access into pulp RADIOGRAPHICALLY (with the use of periapical radiographs) Teeth with
* Internal/ external pathologic root resorption
* Pulp canal obliteration
* Periapical / furcal radiolucency
* Resorbed roots.
* Crestal bone loss Generally patients
* With systemic diseases, bleeding disorders, physical or mental disability, pregnant or nursing.
* On opioid or steroid therapy or anticoagulants and/or on any kind of antibiotics.
* Who have gone through some previous treatment for the same tooth other than filling.
Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ziauddin University

OTHER

Sponsor Role collaborator

Liaquat College of Medicine and Dentistry

OTHER

Sponsor Role lead

Responsible Party

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Naheed Najmi

Vice Principal and Registrar

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Liaquat College of Medicine and Dentistry

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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EC/13/17

Identifier Type: -

Identifier Source: org_study_id

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