Clinical Trial: Vital Pulp Therapy to Treat Irreversible Pulpitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.
Brief Summary: 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 Summary:
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.
Sponsor: Shahid Beheshti University of Medical Sciences
Current Primary Outcome: Clinical and radiographical success of pulpotomy with CEM cement [ Time Frame: 5 year ]
Original Primary Outcome: Non-inferiority of pulpotomy with MTA or a new endodontic filling material [ Time Frame: 24 month ]
Current Secondary Outcome: Patient Assessment of Pain - Visual Analogue Scale [ Time Frame: 7 day ]
Original Secondary Outcome: Same as current
Information By: Shahid Beheshti University of Medical Sciences
Dates:
Date Received: September 4, 2008
Date Started: April 2008
Date Completion:
Last Updated: April 26, 2017
Last Verified: April 2017
