Vital Pulp Therapy (VPT) Using Calcium Enriched Mixture (CEM) to Treat Irreversible Pulpitis

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Irreversible Pulpitis

Treatments: Procedure: Indirect pulp capping (IPC); Procedure: Full pulpotomy (FP); Procedure: Direct pulp capping (DPC); Procedure: Miniature pulpotomy (MP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01561183

IKHDC: 01-11-1390

Details and patient eligibility

About

To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement for management of human dental pulp with irreversible pulpitis.

Full description

The purpose of this randomized clinical trial is to demonstrate the effect of four methods of Vital Pulp Therapy (VPT) using a new endodontic bio-material [calcium enriched mixture (CEM) cement] in pain relief as well as clinical/radiographic success, for management of irreversible pulpitis of human permanent teeth.

Enrollment: 302 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Carious permanent vital mature molar tooth with closed apex (with preoperative X-ray)
2. Positive response to EPT or cold test
3. patients willing to participate in study
4. Healthy subjects; absence of any systematic disorder
5. Age ≥ 10 years old
6. Both gender
7. Written informed consent

Exclusion criteria

1. Moderate or severe periodontitis; pockets >3mm
2. None restorable tooth
3. Internal or external root resorption
4. Root canal calcification
5. Non vital pulps
6. Analgesic taken within the last 8h
7. Active systemic disease
8. Pregnancy or nursing
9. History of opioid addiction/abuse
10. Temporary residency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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302 participants in 4 patient groups

Indirect pulp capping (IPC)

Experimental group

Description:

Indirect pulp capping

Treatment:

Procedure: Indirect pulp capping (IPC)

Direct pulp capping (DPC)

Experimental group

Description:

Direct pulp capping

Treatment:

Procedure: Direct pulp capping (DPC)

Miniature pulpotomy (MP)

Experimental group

Description:

Miniature pulpotomy

Treatment:

Procedure: Miniature pulpotomy (MP)

Full pulpotomy (FP)

Experimental group

Description:

Full pulpotomy

Treatment:

Procedure: Full pulpotomy (FP)