Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste - Full Text View

Sponsor:	The University of Texas Health Science Center at San Antonio
Collaborator:	American Association of Endodontists
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00881491

Purpose

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
Pulp Necrosis	Drug: Double Antibiotic Paste Drug: Triple Antibiotic Paste Drug: Mineral Trioxide Aggregate	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Minerals

Drug Information available for: Statrol Metronidazole hydrochloride Metronidazole phosphate Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate Metronidazole Neocidin Neosporin

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcomes will be lack of clinical symptoms and crown staining. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole	Drug: Double Antibiotic Paste ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.
Experimental: Group B Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline	Drug: Triple Antibiotic Paste ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.
Active Comparator: Group C Group C - Mineral trioxide aggregate: used as an apical barrier	Drug: Mineral Trioxide Aggregate standard material providing an apical barrier

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

Ages Eligible for Study:	7 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

diagnosis of pulpal necrosis with apical periodontitis
children 7-16 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881491

Contacts

Contact: Erin Locke, RN

210-567-0895

locke@uthscsa.edu

Locations

United States, Texas
University of Texas Health Science Center at San Antonio	Recruiting
San Antonio, Texas, United States, 78229
Contact: Erin Locke, RN 210-567-0895 locke@uthscsa.edu
Principal Investigator: Kenneth M Hargreaves, DDS, PhD

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

American Association of Endodontists

Investigators

Principal Investigator:

Kenneth M Hargreaves, DDS, PhD

University of Texas

More Information

No publications provided

Responsible Party:	Kenneth M. Hargreaves, DDS, PhD, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00881491 History of Changes
Other Study ID Numbers:	HSC20090181H
Study First Received:	April 13, 2009
Last Updated:	June 28, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:

Regeneration (revascularization) of dental pulp
Immature (not completely developed) permanent tooth with a diagnosis of

Additional relevant MeSH terms:

Dental Pulp Necrosis
Necrosis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Pathologic Processes
Anti-Bacterial Agents
Bacitracin
Neomycin
Polymyxin B
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Ciprofloxacin
Metronidazole

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Local
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012