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

Tracking Information

First Received Date ^ICMJE

April 13, 2009

Last Updated Date

April 14, 2009

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00881491 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 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.

Study Phase

Phase 0

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

Pulp Necrosis

Intervention ^ICMJE

Drug: Double Antibiotic Paste
ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.
Drug: Triple Antibiotic Paste
ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.
Drug: Mineral Trioxide Aggregate
standard material providing an apical barrier

Study Arms / Comparison Groups

Group A: Experimental
Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole

Intervention: Drug: Double Antibiotic Paste
Group B: Experimental
Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline

Intervention: Drug: Triple Antibiotic Paste
Group C: Active Comparator
Group C - Mineral trioxide aggregate: used as an apical barrier

Intervention: Drug: Mineral Trioxide Aggregate

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 16 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Erin Locke, RN

210-567-0895

locke@uthscsa.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00881491

Responsible Party

Kenneth M. Hargreaves, DDS, PhD, The University of Texas Health Science Center at San Antonio

Study ID Numbers ^ICMJE

HSC20090181H

Study Sponsor ^ICMJE

The University of Texas Health Science Center at San Antonio

Collaborators ^ICMJE

American Association of Endodontists

Investigators ^ICMJE

Principal Investigator:

Kenneth M Hargreaves, DDS, PhD

University of Texas

Information Provided By

The University of Texas Health Science Center at San Antonio

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP