Outcome of Full Pulpotomy Using Calcium Silicate Based Materials

N/AActive Not RecruitingNCT04345263

Jordan University of Science and Technology150 enrolled

Overview

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.

* 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

Carious Teeth

Interventions

MTA pulpotomyPROCEDURE

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Dental teaching centre Faculty Of Dentistry

Irbid, Jordan

Jordan University of science and technology

Irbid, Jordan

Outcomes

Primary Outcomes

Degree of pain relief after treatment compared to preoperative pain level

Absence of symptoms or significant pain reduction within the first week after treatment as measured on a numerical scale from 0 to 10 where zero means no pain and 10 is the most sever pain. Visual analogue scale will be also used.

Time frame: 1 week

Secondary Outcomes

Radiographic normalcy

Absence of pathology in the root and the bone surrounding the apex

Time frame: 1 year and yearly up to 5 years

Data from ClinicalTrials.gov

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