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Sponsors and Collaborators: |
The University of Texas Health Science Center at San Antonio American Association of Endodontists |
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Information provided by: | The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT00881491 |
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.
Condition | Intervention | Phase |
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Pulp Necrosis |
Drug: Double Antibiotic Paste Drug: Triple Antibiotic Paste Drug: Mineral Trioxide Aggregate |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste |
Estimated Enrollment: | 60 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental
Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole
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Drug: Double Antibiotic Paste
ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.
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Group B: Experimental
Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline
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Drug: Triple Antibiotic Paste
ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.
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Group C: Active Comparator
Group C - Mineral trioxide aggregate: used as an apical barrier
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Drug: Mineral Trioxide Aggregate
standard material providing an apical barrier
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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.
Ages Eligible for Study: | 7 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erin Locke, RN | 210-567-0895 | locke@uthscsa.edu |
United States, Texas | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Kenneth M Hargreaves, DDS, PhD | University of Texas |
Responsible Party: | The University of Texas Health Science Center at San Antonio ( Kenneth M. Hargreaves, DDS, PhD ) |
Study ID Numbers: | HSC20090181H |
Study First Received: | April 13, 2009 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00881491 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Regeneration (revascularization) of dental pulp Immature (not completely developed) permanent tooth with a diagnosis of |
Anti-Infective Agents Ciprofloxacin Metronidazole Anti-Bacterial Agents Tooth Diseases |
Minocycline Necrosis Dental Pulp Necrosis Dental Pulp Diseases Stomatognathic Diseases |
Anti-Infective Agents Anti-Bacterial Agents Tooth Diseases Necrosis Pathologic Processes |
Dental Pulp Necrosis Dental Pulp Diseases Therapeutic Uses Stomatognathic Diseases Pharmacologic Actions |