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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Indirect pulp capping (IPC)

Indirect pulp capping

Group Type EXPERIMENTAL

Indirect pulp capping (IPC)

Intervention Type PROCEDURE

Procedure: IPC

The IPC will be performed as follow:

* Anesthesia
* isolation the tooth
* access to the lesion
* incomplete removal of carious tissue from the cavity walls
* indirect pulp capping with ≈2 mm layer calcium enriched mixture cement
* permanent filling with sandwich technique

Direct pulp capping (DPC)

Direct pulp capping

Group Type EXPERIMENTAL

Direct pulp capping (DPC)

Intervention Type PROCEDURE

Procedure: DPC

The DPC will be performed as follow:

* Anesthesia
* isolation the tooth
* access to the lesion
* complete removal of carious tissue from the cavity walls result in pulp exposure
* preparation of clot-free pulpal mound
* direct pulp capping with ≈2 mm layer calcium enriched mixture cement
* permanent filling with sandwich technique

Miniature pulpotomy (MP)

Miniature pulpotomy

Group Type EXPERIMENTAL

Miniature pulpotomy (MP)

Intervention Type PROCEDURE

Procedure: MP

The MP will be performed as follow:

* Anesthesia
* isolation the tooth
* access to the lesion
* complete removal of carious tissue from the cavity walls result in pulp exposure
* intentionally removal of pulp horn (≈1 mm)
* preparation of clot-free pulpal mound
* direct pulp capping with ≈2 mm layer calcium enriched mixture cement
* permanent filling with sandwich technique

Full pulpotomy (FP)

Full pulpotomy

Group Type EXPERIMENTAL

Full pulpotomy (FP)

Intervention Type PROCEDURE

Procedure: FP

The FP will be performed as follow:

* Anesthesia
* isolation the tooth
* access to the lesion
* complete removal of carious tissue from the cavity walls result in pulp exposure
* pulpotomy
* preparation of clot-free pulpal mound
* direct pulp capping with ≈2 mm layer calcium enriched mixture cement
* permanent filling with sandwich technique

Interventions

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Indirect pulp capping (IPC)

Procedure: IPC

The IPC will be performed as follow:

* Anesthesia
* isolation the tooth
* access to the lesion
* incomplete removal of carious tissue from the cavity walls
* indirect pulp capping with ≈2 mm layer calcium enriched mixture cement
* permanent filling with sandwich technique

Intervention Type PROCEDURE

Direct pulp capping (DPC)

Procedure: DPC

The DPC will be performed as follow:

* Anesthesia
* isolation the tooth
* access to the lesion
* complete removal of carious tissue from the cavity walls result in pulp exposure
* preparation of clot-free pulpal mound
* direct pulp capping with ≈2 mm layer calcium enriched mixture cement
* permanent filling with sandwich technique

Intervention Type PROCEDURE

Miniature pulpotomy (MP)

Procedure: MP

The MP will be performed as follow:

* Anesthesia
* isolation the tooth
* access to the lesion
* complete removal of carious tissue from the cavity walls result in pulp exposure
* intentionally removal of pulp horn (≈1 mm)
* preparation of clot-free pulpal mound
* direct pulp capping with ≈2 mm layer calcium enriched mixture cement
* permanent filling with sandwich technique

Intervention Type PROCEDURE

Full pulpotomy (FP)

Procedure: FP

The FP will be performed as follow:

* Anesthesia
* isolation the tooth
* access to the lesion
* complete removal of carious tissue from the cavity walls result in pulp exposure
* pulpotomy
* preparation of clot-free pulpal mound
* direct pulp capping with ≈2 mm layer calcium enriched mixture cement
* permanent filling with sandwich technique

Intervention Type PROCEDURE

Other Intervention Names

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Indirect pulp capping Direct pulp capping Miniature pulpotomy Full pulpotomy

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes