Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste
Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulp Necrosis
Intervention: Double Antibiotic Paste (Drug); Triple Antibiotic Paste (Drug); Mineral Trioxide Aggregate (Drug)
Phase: Phase 0
Status: Terminated
Sponsored by: The University of Texas Health Science Center at San Antonio Official(s) and/or principal investigator(s):
Kenneth M Hargreaves, DDS, PhD, Principal Investigator, Affiliation: The University of Texas Health Science Center at San Antonio
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.
Clinical Details
Official title: Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness.
Secondary outcome: The secondary outcomes will be lack of clinical symptoms and crown staining.
Detailed description:
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.
Eligibility
Minimum age: 7 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- diagnosis of pulpal necrosis with apical periodontitis
- 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:
- non-restorable teeth
- 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
Locations and Contacts
University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States
Additional Information
Starting date: April 2009
Last updated: March 11, 2015
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