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

Study Overview
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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.

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.

Official Title
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Vital Pulp Therapy for Management of Irreversible Pulpitis in Human Permanent Teeth: A Randomized Clinical Trial.

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Procedure: Indirect pulp capping (IPC)
* Procedure: Direct pulp capping (DPC)
* Procedure: Miniature pulpotomy (MP)
* Procedure: Full pulpotomy (FP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Carious permanent vital mature molar tooth with closed apex (with preoperative X-ray) Positive response to EPT or cold test patients willing to participate in study Healthy subjects; absence of any systematic disorder Age ≥ 10 years old Both gender Written informed consent Exclusion Criteria: Moderate or severe periodontitis; pockets >3mm None restorable tooth Internal or external root resorption Root canal calcification Non vital pulps Analgesic taken within the last 8h Active systemic disease Pregnancy or nursing History of opioid addiction/abuse Temporary residency

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indirect pulp capping (IPC)<br>Indirect pulp capping | Procedure: Indirect pulp capping (IPC)<br>* 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<br>* Other names: Indirect pulp capping;|
| Experimental: Direct pulp capping (DPC)<br>Direct pulp capping | Procedure: Direct pulp capping (DPC)<br>* 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<br>* Other names: Direct pulp capping;|
| Experimental: Miniature pulpotomy (MP)<br>Miniature pulpotomy | Procedure: Miniature pulpotomy (MP)<br>* 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<br>* Other names: Miniature pulpotomy;|
| Experimental: Full pulpotomy (FP)<br>Full pulpotomy | Procedure: Full pulpotomy (FP)<br>* 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<br>* Other names: Full pulpotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and radiographical success rates (%) of each treatment group | The outcome of clinical success/failure is determined by subjective symptoms and objective observation of inflammation/infection. The outcome of radiographic success is classified by using a modification of the Strindberg criteria. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Pain with questionnaire | Pain assessment is carried out using the pain Numerical Rating Scale (NRS) with ratings between 0 to 9. Pain assessment is made up to 7 days. One NRS form is given to each patient to complete. | 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vital pulp therapy, Pulp cap, pulpotomy, calcium enriched mixture, CEM cement, Endodontic