Carious Teeth
Conditions
Keywords
teeth, caries, pulpotomy, MTA, biodentine, bioceramic
Brief summary
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.
Detailed description
* 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.
Interventions
PROCEDUREMTA pulpotomy
Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration
Sponsors
Jordan University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain relief after treatment compared to preoperative pain level | 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic normalcy | 1 year and yearly up to 5 years | Absence of pathology in the root and the bone surrounding the apex |
Countries
Jordan
Outcome results
None listed