Outcome of Full Pulpotomy Using Calcium Silicate Based Materials

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2024-05-02

Brief Summary

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Permanent teeth with carious pulp exposure and indicated for full pulpotomy will be treated using three different materials using aseptic technique and will be subsequently followed up clinically and radiographically at 6 months, 1 year and yearly up to 5 years.

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Detailed Description

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* The target sample size is 150 patients medically fit, having vital teeth with carious pulp exposure and complaining of pain.
* The patients tooth will receive full pulpotomy under aseptic conditions and it will be randomly assigned to one of 3 calcium silicate based materials namely, (Mineral trioxide Aggregate (MTA), Biodentine, and Bioceramic for capping the full pulpotomy followed by resin composite restoration.
* Follow up for pain levels will be done during the first week.
* clinical and radiographic examination will be done at 6 months, 1 year and yearly up to 5 years.
* Success of the procedure includes absence of clinical signs and symptoms, with absence of pathology in the root and periapex on periapical radiographs.
* The 3 materials will be compared in terms of clinical and radiographic outcomes.
* demographic data of the three groups will be also compared
* predictive factors of success will be also analyzed
* tooth color changes will be also measured using vita easy shade and will compared between the groups at 6 months and 1 year.

Conditions

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Carious Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Patient unaware of the material to be used, care provider will be given the material after performing full pulpotomy . Tooth crown will be masked during assessment of radiographs

Study Groups

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MTA pulpotomy

Tooth will receive MTA \& resin composite restoration

Group Type ACTIVE_COMPARATOR

MTA pulpotomy

Intervention Type PROCEDURE

Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration

Biodentine pulpotomy

Tooth will receive Biodentine \& resin composite restoration

Group Type ACTIVE_COMPARATOR

MTA pulpotomy

Intervention Type PROCEDURE

Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration

Bioceramic pulpotomy

Tooth will receive Bioceramic \& resin composite restoration

Group Type ACTIVE_COMPARATOR

MTA pulpotomy

Intervention Type PROCEDURE

Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration

Interventions

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MTA pulpotomy

Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration

Intervention Type PROCEDURE

Other Intervention Names

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Biodentine pulpotomy and Bioceramic pulpotomy

Eligibility Criteria

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Inclusion Criteria

* Mature permanent tooth with carious lesion exposing the pulp,
* Positive response to cold test
* Clinical Diagnosis of reversible or irreversible pulpitis
* Restorable tooth by direct restoration or crown
* Healthy patient

Exclusion Criteria

* Non vital teeth
* Teeth without pulp exposure
* Inability to achieve hemostasis within 10 min after pulpotomy
* Non restorable teeth or teeth that require post and core restoration

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes