Iranian Center for Endodontic research
Tehran, 19839, Iran
NCT Number: NCT00748280
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.
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Notify Me9 year–65 year
All sexes
Interventional
Not applicable
Tehran, 19839, Iran
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Other names: single-visit RCT
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.
Time frame: 5 year
Time frame: 7 day
Shahid Beheshti University of Medical Sciences
Other
Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.
Acronym: VPT
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