Vital Pulp Therapy to Treat Irreversible Pulpitis (VPT)
|ClinicalTrials.gov Identifier: NCT00748280|
Recruitment Status : Completed
First Posted : September 8, 2008
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulpitis||Procedure: One-visit root canal therapy Procedure: pulpotomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||615 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2016|
Procedure: One-visit root canal therapy
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 Name: 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.
- Clinical and radiographical success of pulpotomy with CEM cement [ Time Frame: 5 year ]
- Patient Assessment of Pain - Visual Analogue Scale [ Time Frame: 7 day ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748280
|Iran, Islamic Republic of|
|Iranian Center for Endodontic research|
|Tehran, Iran, Islamic Republic of, 19839|
|Study Director:||Mohammad Jafar Eghbal, Prof.||Shahid Beheshti University of Medical Sciences|
|Principal Investigator:||Jamileh Ghoddusi, Prof.||Mashhad University of Medical Sciences|