Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste
NCT ID: NCT00881491
Last Updated: 2016-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
10 participants
INTERVENTIONAL
2009-04-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole
Double Antibiotic Paste
ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.
Group B
Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline
Triple Antibiotic Paste
ciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.
Group C
Group C - Mineral trioxide aggregate: used as an apical barrier
Mineral Trioxide Aggregate
standard material providing an apical barrier
Interventions
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Double Antibiotic Paste
ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.
Triple Antibiotic Paste
ciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.
Mineral Trioxide Aggregate
standard material providing an apical barrier
Eligibility Criteria
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Inclusion Criteria
* patients 7-60 years of age
* maxillary or mandibular restorable single rooted immature permanent tooth with open apices
* acceptance of treatment plan with revascularization procedure
* healthy patient (ASA Class I or II physical status) with no systemic health problems
Exclusion Criteria
* patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report to be a carrier of HIV, undergoing steroid therapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response.
* child subjects unable to give assent
7 Years
60 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Kenneth Hargreaves
Chair, Department of Endodontics
Principal Investigators
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Kenneth M Hargreaves, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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HSC20090181H
Identifier Type: -
Identifier Source: org_study_id
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