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

Shahid Beheshti University of Medical Sciences302 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

302

Conditions

Irreversible Pulpitis

Interventions

Indirect pulp capping (IPC)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)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)PROCEDURE

Eligibility

Sex: ALLMin age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Imam Khomeini Dental Clinic

Tehran, Iran

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 6-months

Data from ClinicalTrials.gov

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