Vital Pulp Therapy to Treat Irreversible Pulpitis
NCT00748280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 615
Last updated 2017-04-28
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.
Conditions
- Pulpitis
Interventions
- 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.
- PROCEDURE
-
pulpotomy
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.
Sponsors & Collaborators
-
Shahid Beheshti University of Medical Sciences
lead OTHER
Principal Investigators
-
Mohammad Jafar Eghbal, Prof. · Shahid Beheshti University of Medical Sciences
-
Jamileh Ghoddusi, Prof. · Mashhad University of Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2008-09-30
- Completion
- 2016-09-30
Countries
- Iran
Study Locations
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