Vital Pulp Therapy to Treat Irreversible Pulpitis
This trial is active, not recruiting.
|Treatments||one-visit root canal therapy, pulpotomy|
|Sponsor||Shahid Beheshti Medical University|
|Start date||April 2008|
|End date||September 2008|
|Trial size||615 participants|
|Trial identifier||NCT00748280, C/B/4/8253|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Primary purpose||health services research|
Clinical and radiographical success of pulpotomy with CEM cement
time frame: 5 year
Patient Assessment of Pain - Visual Analogue Scale
time frame: 7 day
Male or female participants from 9 years up to 65 years old.
Inclusion Criteria: - Diagnostic criteria: 1. Patient reports pain of endodontic origin 2. Diagnosis of irreversible pulpitis - Eligibility criteria: 1. Molar tooth 2. Patient chooses to have tooth extraction for pain relief 3. Age 9-65 years 4. Both gender 5. The patient had read and thoroughly understood the questionnaires; and 6. Written informed consent - Exclusion Criteria: 1. Moderate or severe periodontitis 2. None restorable tooth 3. Internal or external root resorption 4. Root canal calcification 5. No bleeding after access cavity preparation 6. Analgesic taken within the last 4 h 7. Active systemic disease 8. The patient was pregnant or nursing 9. History of opioid addiction or abuse 10. Temporary residency
|Official title||Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.|
|Principal investigator||Jamileh Ghoddusi, Prof.|
|Description||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.|
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