Clinical Trial: Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste

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

Official Title: Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste

Brief Summary: The purpose of this study is to determine the treatment outcomes in permanent teeth with necrotic pulp and immature root development that undergo a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double antibiotic paste (ciprofloxacin, metronidazole)compared to the commonly used mineral trioxide aggregate (MTA) apexification treatment.

Detailed Summary: Recent case series have reported positive outcomes treating necrotic immature permanent teeth with a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline). However, this method can result in considerable staining due to minocycline. In this randomized clinical trial, we will compare clinical outcomes of a triple antibiotic paste versus a double antibiotic paste (ciprofloxacin, metronidazole) intracanal medicament as compared to a standard treatment (immediate apexification with MTA) in permanent teeth with necrotic pulps and immature root development. We hypothesize there will be no significant differences between radiographic measures of root development after treatment with either the double versus triple antibiotic paste, and that both methods will produce significantly greater increases in root length and width compared to standard treatment. The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness and the secondary outcomes will be lack of clinical symptoms and crown staining.
Sponsor: The University of Texas Health Science Center at San Antonio

Current Primary Outcome: The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. [ Time Frame: 3 measurements over 6 months ]

  1. st radiograph taken at 1 month post-procedure completion
  2. nd radiograph taken at 3 month post-procedure completion
  3. rd radiograph taken at 6 month post-procedure completion


Original Primary Outcome: The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. [ Time Frame: one year ]

Current Secondary Outcome: The secondary outcomes will be lack of clinical symptoms and crown staining. [ Time Frame: assessed over the 6 month study period ]

  1. st clinical assessment done at 1 month post-procedure completion
  2. nd clinical assessment done at 3 month post-procedure completion
  3. rd clinical assessment done at 6 month post-procedure completion


Original Secondary Outcome: The secondary outcomes will be lack of clinical symptoms and crown staining. [ Time Frame: one year ]

Information By: The University of Texas Health Science Center at San Antonio

Dates:
Date Received: April 13, 2009
Date Started: April 2009
Date Completion:
Last Updated: February 4, 2016
Last Verified: February 2016