Outcome of Full Pulpotomy Using Calcium Silicate Based Materials (pulpotomy)

Jordan University of Science and Technology

Status: Active, not recruiting

Conditions: Carious Teeth

Treatments: Procedure: MTA pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04345263

503/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

150 participants in 3 patient groups

MTA pulpotomy

Active Comparator group

Description:

Tooth will receive MTA \& resin composite restoration

Treatment:

Procedure: MTA pulpotomy

Biodentine pulpotomy

Active Comparator group

Description:

Tooth will receive Biodentine \& resin composite restoration

Treatment:

Procedure: MTA pulpotomy

Bioceramic pulpotomy

Active Comparator group

Description:

Tooth will receive Bioceramic \& resin composite restoration

Treatment:

Procedure: MTA pulpotomy