Vital Pulp Therapy to Treat Irreversible Pulpitis

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with new endodontic bio-materials) as a new treatment with one-visit root canal therapy as reference treatment in pain relief and clinical and radiographic success, for irreversible pulpitis of human permanent molar teeth.

Detailed Description
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In one visit RCT (Arm 1): The teeth were anesthetized, isolated and endodontic access and instrumentation of all canals was done. Canal preparation was conducted using a step-back technique. The working lengths were determined and confirmed by radiography. Sterile normal saline solution was used for intra-canal irrigation. Root canals were obturated with gutta-percha and sealer using lateral condensation technique. After placing a cotton pellet in the pulp chamber, the access cavity was closed with Cavit. In pulpotomy treatment with CEM/MTA (Arm 2): The teeth were anesthetized. Pulpotomy procedure of removing inflamed pulp tissue to the stump level was done. Homeostasis was achieved by irrigating the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The pulpal wound was covered with an approximately 2-mm-thick layer of MTA/CEM cement. Pulp chambers were then covered with a wet cotton pellet and sealed with Cavit.

Official Title
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Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.

Conditions
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Pulpitis

Intervention / Treatment
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* Procedure: One-visit root canal therapy
* Procedure: pulpotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic criteria: Patient reports pain of endodontic origin Diagnosis of irreversible pulpitis Eligibility criteria: Molar tooth Patient chooses to have tooth extraction for pain relief Age 9-65 years Both gender The patient had read and thoroughly understood the questionnaires; and Written informed consent Exclusion Criteria: Moderate or severe periodontitis None restorable tooth Internal or external root resorption Root canal calcification No bleeding after access cavity preparation Analgesic taken within the last 4 h Active systemic disease The patient was pregnant or nursing History of opioid addiction or abuse Temporary residency

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 65 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ORCT | Procedure: One-visit root canal therapy<br>* Teeth were isolated, caries was removed and access cavities were prepared. Canal preparation was conducted using step-back technique. The working lengths were determined and confirmed by radiographs. The minimum size file for preparing the working length was size ISO #25 K-file to within 0.5-2 mm of the radiographic apex of the root. During hand instrumentation, canals were frequently irrigated with adequate amount of sterile normal saline solution. The root canals were filled with multiple gutta-percha cones and sealer using lateral condensation technique. Placing a cotton pellet in the pulp chamber, the access cavity was temporarily filled. The treatments of all samples were performed one-visit.<br>* Other names: single-visit RCT;|
| Experimental: 2<br>PCEM/PMTA | Procedure: pulpotomy<br>* Pulpotomy was performed with a large round bur in a high-speed handpiece with copious irrigation; removing inflamed pulp tissue to stump level. Hemostasis was achieved by irrigation of the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The blood clot-free pulpal wound was covered with approximately 2 mm layer of endodontic bio-materials, a sterile wet cotton pellet was then placed over the MTA/CEM cement and the cavity sealed with Cavit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and radiographical success of pulpotomy with CEM cement |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Pain - Visual Analogue Scale |  | 7 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endodontics, CEM cement, Calcium enriched mixture, MTA, Root Canal Therapy, Pain, Pulpotomy, Human, Permanent, Molar teeth