Clinical Trial: Vital Pulp Therapy (VPT) Using Calcium Enriched Mixture (CEM) to Treat Irreversible Pulpitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Vital Pulp Therapy for Management of Irreversible Pulpitis in Human Permanent Teeth: A Randomized Clinical Trial.

Brief Summary: To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement for management of human dental pulp with irreversible pulpitis.

Detailed Summary: The purpose of this randomized clinical trial is to demonstrate the effect of four methods of Vital Pulp Therapy (VPT) using a new endodontic bio-material [calcium enriched mixture (CEM) cement] in pain relief as well as clinical/radiographic success, for management of irreversible pulpitis of human permanent teeth.
Sponsor: Shahid Beheshti University of Medical Sciences

Current Primary Outcome: Clinical and radiographical success rates (%) of each treatment group [ Time Frame: 1 year ]

The outcome of clinical success/failure is determined by subjective symptoms and objective observation of inflammation/infection.

The outcome of radiographic success is classified by using a modification of the Strindberg criteria.



Original Primary Outcome: Same as current

Current Secondary Outcome: Patient Assessment of Pain with questionnaire [ Time Frame: 6-months ]

Pain assessment is carried out using the pain Numerical Rating Scale (NRS) with ratings between 0 to 9. Pain assessment is made up to 7 days. One NRS form is given to each patient to complete.


Original Secondary Outcome: Same as current

Information By: Shahid Beheshti University of Medical Sciences

Dates:
Date Received: March 14, 2012
Date Started: March 2012
Date Completion:
Last Updated: April 26, 2017
Last Verified: April 2017