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Trial NCT00748280

Resource URI: http://static.linkedct.org/resource/trials/NCT00748280
linkedct:acronym VPT
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/13829>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/188>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/24199>
linkedct:brief_title Vital Pulp Therapy to Treat Irreversible Pulpitis
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5948>
linkedct:condition <http://static.linkedct.org/resource/condition/11030>
linkedct:criteria 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
linkedct:description In one visit RCT (Arm 1): The teeth were anaesthetized, 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 radiographs. Sterile normal saline solution was used for intracanal 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 mineral trioxide aggregate (Arm 2) or new endodontic cement (Arm 3): The teeth were anaesthetized. 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 or NEC. Cements were then covered with a wet cotton pellet and sealed with Cavit.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 65 Years
linkedct:eligibility_minimum_age 9 Years
linkedct:end_date September 2010
linkedct:enrollment 600 (xsd:int)
linkedct:firstreceived_date September 4, 2008
linkedct:has_dmc Yes
linkedct:id NCT00748280
rdfs:label Trial NCT00748280
linkedct:lastchanged_date September 8, 2008
linkedct:lead_sponsor_agency Shaheed Beheshti Medical University
linkedct:location <http://static.linkedct.org/resource/location/73077>
linkedct:nct_id NCT00748280
linkedct:number_of_arms 3 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-Inferiority Trial.
linkedct:org_study_id C/B/4/8253
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/25469>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/39372>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/42265>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/1388>
foaf:page <http://clinicaltrials.gov/show/NCT00748280>
linkedct:phase Phase 3
linkedct:primary_completion_date September 2008
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/37930>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/80000>
linkedct:source Shaheed Beheshti Medical University
linkedct:start_date April 2008
linkedct:study_design Health Services Research, Randomized, Open Label, Parallel Assignment
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with mineral trioxide aggregate or new endodontic cement) as a new treatment with root canal therapy as reference treatment in pain relief and clinical and radiographic success, for irreversible pulpitis of human permanent molar teeth.
rdf:type linkedct:trials
linkedct:verification_date August 2008